Hanarostent®
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- HANAROSTENT® EUDAMEDHANAROSTENT® Esophagus TTS(NCN) FDA UDIHANAROSTENT® Trachea/Bronchium(CCC) FDA UDIHANAROSTENT® Biliary (NNN) FDA UDIHANAROSTENT® Esophagus (NCN) FDA UDIHANAROSTENT® LowAxTM Colon/Rectum(NNN) FDA UDIHANAROSTENT® Esophagus Asymmetric (CCC) FDA UDI
- Generic Name
- Polymer-metal oesophageal stent FDA UDIPolymer-metal tracheal/bronchial stent FDA UDIBare-metal biliary stent FDA UDIBare-metal colonic stent FDA UDI
- Device Name
- Pancreatic drainage stent with Electrocautery Delivery System EUDAMEDColon/Rectum Stent with Delivery System EUDAMEDEsophageal Stent with Delivery System EUDAMEDBiliary Stent with Delivery System EUDAMEDDuodenal Pyloric Stent with Delivery System EUDAMEDTrachea/Bronchium Stent with Delivery System EUDAMEDPancreatic drainage stent with Delivery System EUDAMEDPartially Covered metallic esophagus stent FDA UDIFull Covered metallic tracheal stent FDA UDIUn-covered self-expanding nitinol biliary stent FDA UDIUn-covered self-expanding nitinol colon stent FDA UDIFull Covered metallic esophagus stent FDA UDI
- Model / Reference
- HANAROSTENT® HOT PlumberTM with Z-EUS IT™ EUDAMEDBCF-16-040-T140 EUDAMEDHANAROSTENT® Colon/Rectum Lasso (NNN) EUDAMEDCNZ-22-140-230 EUDAMEDHANAROSTENT® Esophagus Valve (CCC) EUDAMEDHESV-18-120-070 EUDAMEDHANAROSTENT® Biliary Flap (CCC) EUDAMEDBCG-10-070-180 EUDAMEDHANAROSTENT® Biliary Flap Lasso (CCC) EUDAMEDBCT-08-060-180 EUDAMEDHANAROSTENT® Duodenum/Pylorus Lasso (NNN) EUDAMEDNDSL-20-170-230 EUDAMEDHANAROSTENT® Duodenum/Pylorus Kim’s Flare (NCN) EUDAMEDDPDL-20-080-230 EUDAMEDDPDL-20-090-230 EUDAMEDCNZ-22-130-230 EUDAMEDHANAROSTENT® Biliary (NC) EUDAMEDBPN-08-040-060 EUDAMEDCHOOSTENT® Colon/Rectum (CCC) EUDAMEDHCC-24-060-070 EUDAMEDHANAROSTENT® Esophagus Benign BS (CCC) EUDAMEDEBN22080-Z070 EUDAMEDCHOOSTENT® Esophagus Asymmetric (CCC) EUDAMEDNESA-18-060-070 EUDAMEDHANAROSTENT® Biliary (NCN) EUDAMEDBPA08060-R060 EUDAMEDHANAROSTENT® Esophagus Upper (CCC) EUDAMEDECP20120-X070 EUDAMEDBCT-08-080-180 EUDAMEDHANAROSTENT® Intestine Asymmetric (NCN) EUDAMEDHRC-20-060-230 EUDAMEDCNZ-24-170-230 EUDAMEDEBN24100-Z070 EUDAMEDHANAROSTENT ® Esophagus Lasso (NNN) EUDAMEDHNS-22-120-070 EUDAMEDNESA-18-130-070 EUDAMEDHANAROSTENT® Biliary (NNN) EUDAMEDBNA10070-H060 EUDAMEDHANAROSTENT® Biliary Lasso (CCC) EUDAMEDBCB10060-E180 EUDAMEDHANAROSTENT® Gastro-Seal™ Esophagus ST (CCC) EUDAMEDECBST-26-210-090 EUDAMEDBCBC10120-B180 EUDAMEDBPN-08-060-180 EUDAMEDBCG-10-060-060 EUDAMEDECP18150-X070 EUDAMEDHANAROSTENT® Biliary Hilar (NNN) EUDAMEDBNY-08-080-060 EUDAMEDBNL-10-100-180 EUDAMEDHANAROSTENT® Multi-Hole™ Biliary (CCC) EUDAMEDBMCL-10-060-180 EUDAMEDBCS10040-R060 EUDAMEDHANAROSTENT® Biliary (CCC) EUDAMEDBCA08100-Q060 EUDAMEDBPF-10-080-180 EUDAMEDSHC-10-040-180 EUDAMEDBCA08070-E230 EUDAMEDHANAROSTENT® Esophagus Valve BS (CCN) EUDAMEDEPV-22-160-070 EUDAMEDEBN18080-Z070 EUDAMEDDPDL-20-090-120 EUDAMEDHANAROSTENT® Esophagus (CCC) EUDAMEDHES-22-180-070 EUDAMEDNCSL-24-140-140 EUDAMEDHANAROSTENT® Esophagus (NCN) EUDAMEDEPB18140-X070 EUDAMEDFDA UDINCSL-24-140-230 EUDAMEDHANAROSTENT® Esophagus Valve BS (CCC) EUDAMEDECW22090-Z070 EUDAMEDCHOOSTENT® Esophagus (CCC) EUDAMEDNES-22-110-070 EUDAMEDHESV-22-090-070 EUDAMEDHANAROSTENT® Gastro-Seal™ Esophagus (CCC) EUDAMEDECBS-26-210-090 EUDAMEDSHCL-06-040-180 EUDAMEDBCS10060-R060 EUDAMEDBNY-10-080-180 EUDAMEDBMCL-10-120-180 EUDAMEDSHC-10-080-060 EUDAMEDHANAROSTENT® Esophagus Skidproof (CCC) EUDAMEDECD-20-080-070 EUDAMEDCHOOSTENT® Esophagus Upper ST (CCC) EUDAMEDNESCT-18-140-070 EUDAMEDHANAROSTENT® Esophagus Benign BS ST (CCC) EUDAMEDEBNT22080-Z070 EUDAMEDEBN22060-Z070 EUDAMEDBCB10100-Q060 EUDAMEDHANAROSTENT® Trachea/Bronchium (CCC) EUDAMEDNTS-20-040-090 EUDAMEDEPB18060-X070 EUDAMEDNTS-18-030-050 EUDAMEDBCG-08-120-180 EUDAMEDSHCL-08-070-180 EUDAMEDHANAROSTENT® Esophagus BS (CCC) EUDAMEDNES-28-140-070 EUDAMEDNCSL-24-120-230 EUDAMEDBCT-08-100-180 EUDAMEDHANAROSTENT® TwynLay™ Duodenum/Pylorus (NCN) EUDAMEDTLD-20-170-230 EUDAMEDHANAROSTENT® Esophagus Asymmetric (CCC) EUDAMEDECN24180-Z070 EUDAMEDNES-22-140-070 EUDAMEDHANAROSTENT® Biliary Valve (NNN) EUDAMEDBNX-10-060-180 EUDAMEDBCT-10-040-060 EUDAMEDECW18120-Z070 EUDAMEDEBN18100-Z070 EUDAMEDHANAROSTENT® TwynLay™ Colon/Rectum (NCN) EUDAMEDTLC-24-080-230 EUDAMEDNTS-10-030-090 EUDAMEDBCF-12-040-T140 EUDAMEDHANAROSTENT® Benefit™ Biliary (NNN) EUDAMEDBNHS-06-080-180 EUDAMEDHANAROSTENT® TwynLay™ DuodenumPylorus (NCN) TLD-20-060-120 EUDAMEDTLD-20-060-120 EUDAMEDBNA10080-H060 EUDAMEDBCT-08-040-180 EUDAMEDBCA08100-E180 EUDAMEDCHOOSTENT® Esophagus ST (CCN) EUDAMEDNES-18-070-070 EUDAMEDECP18060-X070 EUDAMEDEPB18170-X070 EUDAMEDBNA08050-G180 EUDAMEDHANAROSTENT® Duodenum/Pylorus Lasso (NCN) EUDAMEDNDCL-20-120-230 EUDAMEDBCF-16-020-T140 EUDAMEDBCB10080-E180 EUDAMEDNDSL-20-060-230 EUDAMEDNES-28-170-070 EUDAMEDHANAROSTENT® Plumber™ Biliary (CCC) EUDAMEDBCF-14-020-180 EUDAMEDBCBC10100-B180 EUDAMEDNDSL-20-120-230 EUDAMEDHCC-24-120-070 EUDAMEDEND20100-C070 EUDAMEDBNX-08-080-180 EUDAMEDHNS-22-160-070 EUDAMEDHANAROSTENT® Duodenum/Pylorus (NNN) EUDAMEDNDS-20-100-230 EUDAMEDNTS-14-040-090 EUDAMEDBNA08050-Q060 EUDAMEDNDSL-20-080-230 EUDAMEDCHOOSTENT® Esophagus Valve (CCN) EUDAMEDEPF18100-Z070 EUDAMEDHES-18-050-070 EUDAMEDECD-20-100-070 EUDAMEDDNZL-20-160-230 EUDAMEDHANAROSTENT® LowAx™ Colon/Rectum (NNN) EUDAMEDCNJF-22-100-140 EUDAMEDECW22100-Z070 EUDAMEDBCS10090-D180 EUDAMEDNTS-16-030-050 EUDAMEDHANAROSTENT® Esophagus Bariatric Surgery (CCC) EUDAMEDECBB-30-180-090 EUDAMEDSHCL-10-080-180 EUDAMEDEPB22060-Z070 EUDAMEDNCSL-24-080-140 EUDAMEDEPF18080-Z070 EUDAMEDBCF-14-030-T140 EUDAMEDEPV-18-100-070 EUDAMEDBNL-10-060-060 EUDAMEDBNA10040-Q060 EUDAMEDDNZL-22-080-230 EUDAMEDBMCL-08-040-180 EUDAMEDDNZL-20-060-230 EUDAMEDTLC-20-110-230 EUDAMEDBCT-10-100-060 EUDAMEDNES-22-090-070 EUDAMEDBNY-10-120-060 EUDAMEDHES-22-060-070 EUDAMEDDNZL-20-090-230 EUDAMEDECBB-28-180-090 EUDAMEDBCG-10-050-180 EUDAMEDHANAROSTENT® TracheaBronchium (CCC) EUDAMEDNTS-16-040-050 EUDAMEDBCG-08-040-180 EUDAMEDHANAROSTENT® Colon/Rectum TTS (CCC) EUDAMEDCCBA-20-090-230 EUDAMEDDPDL-20-120-230 EUDAMEDHANAROSTENT® Colon/Rectum (NNN) EUDAMEDNCS-24-090-230 EUDAMEDHANAROSTENT® Luso-Cor esophageal stent EUDAMEDHCBB-2030-240-090 EUDAMEDECW18140-Z070 EUDAMEDBMCL-10-100-180 EUDAMEDEBNT18100-Z070 EUDAMEDSHCL-08-040-180 EUDAMEDBCT-10-120-180 EUDAMEDBCT-10-080-180 EUDAMEDECP18100-X070 EUDAMEDBNA10080-G180 EUDAMEDNTS-18-040-050 EUDAMEDCCBA-20-130-230 EUDAMEDCNZ-22-150-230 EUDAMEDBMCL-10-080-060 EUDAMEDBCS10080-R060 EUDAMEDDNZL-20-120-230 EUDAMEDHRC-20-090-230 EUDAMEDHANAROSTENT® Esophagus Valve (CCN) EUDAMEDEPC-18-160-070 EUDAMEDBNHS-06-100-180 EUDAMEDNCS-22-140-230 EUDAMEDBCA08110-Q060 EUDAMEDBCG-08-090-180 EUDAMEDHESV-22-060-070 EUDAMEDBCB10060-Q060 EUDAMEDEBN24120-Z070 EUDAMEDBCG-06-080-180 EUDAMEDBNA08070-G180 EUDAMEDECBS-28-210-090 EUDAMEDTLC-22-060-230 EUDAMEDBCF-14-040-180 EUDAMEDCNZ-24-110-230 EUDAMEDBCF-14-030-180 EUDAMEDBNY-10-060-180 EUDAMEDECV20140-X070 EUDAMEDBCS10040-D180 EUDAMEDTLC-20-160-230 EUDAMEDBCB08040-E180 EUDAMEDHCBB-2036-240-090 EUDAMEDBCB10050-E180 EUDAMEDEPG22090-Z070 EUDAMEDBPN-10-080-180 EUDAMEDCHOOSTENT® Esophagus Valve ST (CCN) EUDAMEDHEVT-22-140-070 EUDAMEDDNZL-20-100-230 EUDAMEDECW22160-Z070 EUDAMEDNES-20-060-070 EUDAMEDHES-18-060-070 EUDAMEDDNZL-22-140-230 EUDAMEDTLC-22-120-230 EUDAMEDBCF-16-020-180 EUDAMEDECD-20-140-070 EUDAMEDEPG22060-Z070 EUDAMEDHANAROSTENT® Colon/Rectum Asymmetric (CCC) EUDAMEDCCN22080-Z070 EUDAMEDECP18070-X070 EUDAMEDEPG22100-Z070 EUDAMEDBCF-10-040-180 EUDAMEDBMCL-10-040-060 EUDAMEDHANAROSTENT® Colon/Rectum (CCC) EUDAMEDCCB24090-Z070 EUDAMEDTLC-20-100-230 EUDAMEDDPDL-20-130-230 EUDAMEDCNJF-25-080-140 EUDAMEDEPB22170-Z070 EUDAMEDBPA08100-R060 EUDAMEDBPA10050-D180 EUDAMEDNCSL-22-080-230 EUDAMEDSHCL-10-100-180 EUDAMEDECV20110-X070 EUDAMEDNESA-18-090-070 EUDAMEDHANAROSTENT® Esophagus BS (NCN) EUDAMEDEPW-20-110-070 EUDAMEDDPDL-20-130-120 EUDAMEDBNA08080-G180 EUDAMEDEBN20080-Z070 EUDAMEDCNZ-22-120-230 EUDAMEDCHOOSTENT® Esophagus Valve (CCC) EUDAMEDHEV-18-080-070 EUDAMEDBPN-08-080-180 EUDAMEDBNA10100-G180 EUDAMEDCCBA-20-110-230 EUDAMEDBPE-08-070-180 EUDAMEDBCA08080-Q060 EUDAMEDBCF-12-030-T140 EUDAMEDHANAROSTENT® Duodenum/Pylorus Kim’s Flare (CCN) EUDAMEDDPC-20-150-230 EUDAMEDBCBC08100-B180 EUDAMEDNES-18-120-070 EUDAMEDDPDL-20-100-230 EUDAMEDHESV-18-090-070 EUDAMEDSHCL-08-060-180 EUDAMEDBCS10100-R060 EUDAMEDNTS-12-030-090 EUDAMEDBNL-10-040-060 EUDAMEDHANAROSTENT® Plumber™ EUDAMEDTLD-22-110-230 EUDAMEDBNY-08-100-060 EUDAMEDBMCL-10-050-180 EUDAMEDBPE-08-060-180 EUDAMEDCCB24080-Z070 EUDAMEDBCF-14-020-T140 EUDAMEDTLC-24-120-230 EUDAMEDBPA10060-R060 EUDAMEDSHCL-10-040-180 EUDAMEDNES-18-080-070 EUDAMEDNES-28-110-070 EUDAMEDECBB-30-210-090 EUDAMEDCNJF-25-080-230 EUDAMEDBMCL-10-080-180 EUDAMEDBNA10060-H060 EUDAMEDDNZL-20-110-120 EUDAMEDBPN-10-040-180 EUDAMEDBCG-10-080-060 EUDAMEDEBNT22120-Z070 EUDAMEDBCG-06-060-180 EUDAMEDNESA-18-110-070 EUDAMEDBCF-16-030-T140 EUDAMEDCNZ-24-100-230 EUDAMEDNDCL-20-060-230 EUDAMEDTLD-22-140-230 EUDAMEDEPF22160-Z070 EUDAMEDTLC-22-080-230 EUDAMEDNTS-12-030-050 EUDAMEDECV20100-X070 EUDAMEDEBN20060-Z070 EUDAMEDBPN-10-070-060 EUDAMEDCNJF-22-100-230 EUDAMEDBCG-08-060-180 EUDAMEDNTS-14-030-090 EUDAMEDBCB08100-E180 EUDAMEDHNS-22-090-070 EUDAMEDHANAROSTENT® FAST™ Biliary Flap (CCC) EUDAMEDBCG-10-100-S180 EUDAMEDBCBC08080-B180 EUDAMEDBCT-10-050-180 EUDAMEDBNL-08-100-180 EUDAMEDTLC-24-100-230 EUDAMEDBNA10080-Q060 EUDAMEDDPC-20-110-230 EUDAMEDBCG-10-040-060 EUDAMEDBPE-10-080-180 EUDAMEDBPN-10-080-060 EUDAMEDBPN-08-050-060 EUDAMEDCCN22060-Z070 EUDAMEDBNX-10-080-180 EUDAMEDNCSL-24-080-230 EUDAMEDDNZL-20-140-230 EUDAMEDTLD-20-110-230 EUDAMEDBPA08080-R060 EUDAMEDNDSL-20-080-120 EUDAMEDEND18100-C070 EUDAMEDCHOOSTENT® Esophagus (NCN) EUDAMEDEPE18140-X070 EUDAMEDTLC-22-140-230 EUDAMEDNTS-20-060-090 EUDAMEDCHOOSTENT® Colon/Rectum Asymmetric (CCC) EUDAMEDCCI24050-Z070 EUDAMEDSHC-10-060-180 EUDAMEDBCG-10-080-180 EUDAMEDCCI24150-Z070 EUDAMEDBCBC10050-B180 EUDAMEDECV20170-X070 EUDAMEDEPG22140-Z070 EUDAMEDSHC-10-120-180 EUDAMEDBPN-10-060-180 EUDAMEDBCA08060-Q060 EUDAMEDCCB24060-Z070 EUDAMEDBPN-10-090-180 EUDAMEDNDCL-20-140-230 EUDAMEDBCF-10-030-T140 EUDAMEDBPA10100-R060 EUDAMEDECBS-26-180-090 EUDAMEDEPC-22-160-070 EUDAMEDNCSL-24-110-140 EUDAMEDDPC-20-090-230 EUDAMEDDNZL-20-080-230 EUDAMEDBMCL-08-080-180 EUDAMEDCHOOSTENT® Esophagus Upper (CCC) EUDAMEDNESC-18-060-070 EUDAMEDEPE18150-X070 EUDAMEDBPA10120-D180 EUDAMEDBNX-10-100-180 EUDAMEDBCG-08-080-180 EUDAMEDECV20060-X070 EUDAMEDCNZ-22-060-230 EUDAMEDBCG-08-080-S180 EUDAMEDEPW-20-150-070 EUDAMEDCCBA-20-060-230 EUDAMEDEBN18120-Z070 EUDAMEDNES-18-060-070 EUDAMEDNDCL-18-110-230 EUDAMEDBNL-10-080-060 EUDAMEDBPN-10-100-180 EUDAMEDEBN18060-Z070 EUDAMEDSHC-08-040-180 EUDAMEDBCF-12-020-180 EUDAMEDBCT-10-100-180 EUDAMEDBCB10040-Q060 EUDAMEDEPW-20-080-070 EUDAMEDBCB10100-E180 EUDAMEDBNA08100-H060 EUDAMEDEND20120-C070 EUDAMEDBCA08050-E230 EUDAMEDBNY-08-060-060 EUDAMEDNDCL-20-080-120 EUDAMEDECP18080-X070 EUDAMEDSHC-08-080-180 EUDAMEDBMCL-10-100-060 EUDAMEDCCBA-20-100-230 EUDAMEDBPA10060-D180 EUDAMEDCNZ-22-100-230 EUDAMEDHANAROSTENT® Duodenum/Pylorus (NCN) EUDAMEDNDC-20-090-230 EUDAMEDHNS-22-140-070 EUDAMEDTLC-20-060-230 EUDAMEDNCSL-22-110-230 EUDAMEDSHCL-10-120-180 EUDAMEDCCN22120-Z070 EUDAMEDSHCL-08-080-180 EUDAMEDCNZ-22-080-230 EUDAMEDNESCT-18-080-070 EUDAMEDHANAROSTENT® Esophagus Bariatric Surgery ST (CCC) EUDAMEDECBBT-28-240-090 EUDAMEDNCSL-24-170-230 EUDAMEDNES-28-120-070 EUDAMEDCCN22100-Z070 EUDAMEDHCC-24-170-070 EUDAMEDCNZ-24-140-230 EUDAMEDECBBT-30-240-090 EUDAMEDNCSL-24-170-140 EUDAMEDNDCL-20-090-230 EUDAMEDSHC-10-090-060 EUDAMEDEPBA-20-100-230 EUDAMEDFDA UDITCS-12-020-050 EUDAMEDFDA UDISHS-08-050-180 EUDAMEDFDA UDISHS-10-060-180 EUDAMEDFDA UDICNJF-22-120-230 EUDAMEDFDA UDISHS-08-060-060 EUDAMEDFDA UDIEPB18080-X070 EUDAMEDFDA UDIECN18090-X070 EUDAMEDFDA UDISHS-08-120-180 EUDAMEDFDA UDIEPB22100-Z070 EUDAMEDFDA UDIEPBA-18-130-180 EUDAMEDFDA UDIBNHS-08-060-060 EUDAMEDBPD-10-080-180 EUDAMEDCCN24110-Z070 EUDAMEDSHCL-08-050-180 EUDAMEDSHCL-10-060-180 EUDAMEDNESCT-18-100-070 EUDAMEDBCBC10060-N060 EUDAMEDBPN-10-050-060 EUDAMEDTLC-22-140-140 EUDAMEDNDCL-20-090-120 EUDAMEDNESC-18-100-070 EUDAMEDSHS-08-060-180 EUDAMEDBNA10060-G180 EUDAMEDHANAROSTENT® Esophagus TTS (NCN) EUDAMEDBNA08060-G180 EUDAMEDHESV-22-170-070 EUDAMEDEPF18150-Z070 EUDAMEDBCF-12-030-180 EUDAMEDSHC-10-040-060 EUDAMEDBNY-08-100-180 EUDAMEDSHC-10-100-180 EUDAMEDBCG-08-100-180 EUDAMEDSHCL-06-100-180 EUDAMEDBPE-10-060-180 EUDAMEDNDCL-18-060-230 EUDAMEDTLC-22-100-230 EUDAMEDBCBC10040-B180 EUDAMEDECBB-30-240-090 EUDAMEDECV20080-X070 EUDAMEDNTS-10-040-090 EUDAMEDEPW-20-100-070 EUDAMEDCNZ-22-110-230 EUDAMEDEPW-20-120-070 EUDAMEDEPG22120-Z070 EUDAMEDDPC-20-080-230 EUDAMEDECBB-28-240-090 EUDAMEDHEVT-22-120-070 EUDAMEDCCN24080-Z070 EUDAMEDBCA10100-Q060 EUDAMEDBPN-08-100-060 EUDAMEDTLC-22-100-140 EUDAMEDBNA08040-G180 EUDAMEDNDS-20-080-120 EUDAMEDBNY-08-060-180 EUDAMEDNCSL-24-110-230 EUDAMEDBNA10060-Q060 EUDAMEDSHC-10-060-060 EUDAMEDNDCL-20-070-230 EUDAMEDHANAROSTENT® Naturfit™ Colon/Rectum (NNN) EUDAMEDCNHS-22-090-230 EUDAMEDDNZL-22-060-230 EUDAMEDEBN20100-Z070 EUDAMEDBNY-08-080-180 EUDAMEDECP18170-X070 EUDAMEDEPG22110-Z070 EUDAMEDTLC-24-140-230 EUDAMEDBCG-10-060-180 EUDAMEDEPE18120-X070 EUDAMEDSHS-08-080-060 EUDAMEDBCB08060-E180 EUDAMEDCCBA-20-120-230 EUDAMED
- Description
- Partially Covered metallic esophagus stent FDA UDIFull Covered metallic tracheal stent FDA UDIUn-covered self-expanding nitinol biliary stent FDA UDIUn-covered self-expanding nitinol colon stent FDA UDIFull Covered metallic esophagus stent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806367093233 EUDAMED08806367050779 EUDAMED08806367021786 EUDAMED08806367087089 EUDAMED08806367086266 EUDAMED08806367068910 EUDAMED08806367063281 EUDAMED08806367063298 EUDAMED08806367038357 EUDAMED08806367074089 EUDAMED08806367017819 EUDAMED08806367035936 EUDAMED08806367016218 EUDAMED08806367040114 EUDAMED08806367044327 EUDAMED08806367086280 EUDAMED08806367024886 EUDAMED08806367050922 EUDAMED08806367047236 EUDAMED08806367045119 EUDAMED08806367016249 EUDAMED08806367061461 EUDAMED08806367068323 EUDAMED08806367077868 EUDAMED08806367031303 EUDAMED08806367044594 EUDAMED08806367087256 EUDAMED08806367039651 EUDAMED08806367037619 EUDAMED08806367067524 EUDAMED08806367087430 EUDAMED08806367086877 EUDAMED08809867550183 EUDAMED08806367049193 EUDAMED08806367017024 EUDAMED08809867550138 EUDAMED08806367022837 EUDAMED08806367035875 EUDAMED08806367072368 EUDAMED08806367026293 EUDAMED08806367058577 EUDAMED08806367039507 EUDAMEDFDA UDI08806367058454 EUDAMED08806367016256 EUDAMED08806367026255 EUDAMED08806367023971 EUDAMED08806367087690 EUDAMED08806367044006 EUDAMED08806367086891 EUDAMED08806367037411 EUDAMED08806367087492 EUDAMED08806367016706 EUDAMED08806367046116 EUDAMED08806367040893 EUDAMED08806367030122 EUDAMED08806367035929 EUDAMED08806367074706 EUDAMED08806367019486 EUDAMED08806367071958 EUDAMED08806367029614 EUDAMED08806367087041 EUDAMED08806367017239 EUDAMED08806367047403 EUDAMED08806367058430 EUDAMED08806367086303 EUDAMED08806367049803 EUDAMED08806367044808 EUDAMED08806367023483 EUDAMED08806367033949 EUDAMED08806367086518 EUDAMED08806367040459 EUDAMED08806367036100 EUDAMED08806367062369 EUDAMED08806367004390 EUDAMED08806367093172 EUDAMED08806367075666 EUDAMED08806367049452 EUDAMED08806367061478 EUDAMED08806367086242 EUDAMED08809867550176 EUDAMED08809867555249 EUDAMED08806367039644 EUDAMED08806367039514 EUDAMED08806367061539 EUDAMED08806367032577 EUDAMED08806367093219 EUDAMED08806367068347 EUDAMED08806367068804 EUDAMED08806367047410 EUDAMED08806367064844 EUDAMED08806367030863 EUDAMED08806367068866 EUDAMED08806367017857 EUDAMED08806367073938 EUDAMED08806367033840 EUDAMED08806367045133 EUDAMED08806367061867 EUDAMED08806367019394 EUDAMED08806367074270 EUDAMED08806367068828 EUDAMED08806367027030 EUDAMED08806367004116 EUDAMED08806367046529 EUDAMED08806367051486 EUDAMED08806367080691 EUDAMED08806367074539 EUDAMED08806367086747 EUDAMED08806367029546 EUDAMED08806367035950 EUDAMED08806367017338 EUDAMED08806367071965 EUDAMED08806367058515 EUDAMED08806367027023 EUDAMED08806367093196 EUDAMED08806367077783 EUDAMED08806367069382 EUDAMED08806367073488 EUDAMED08806367064998 EUDAMED08806367087324 EUDAMED08806367051400 EUDAMED08806367050144 EUDAMED08806367086570 EUDAMED08806367036612 EUDAMED08806367037213 EUDAMED08806367026286 EUDAMED08806367051424 EUDAMED08806367048110 EUDAMED08806367087065 EUDAMED08806367019226 EUDAMED08806367086969 EUDAMED08806367031129 EUDAMED08806367063250 EUDAMED08806367020956 EUDAMED08806367064387 EUDAMED08806367075260 EUDAMED08806367040466 EUDAMED08806367087478 EUDAMED08806367066947 EUDAMED08806367017208 EUDAMED08806367086419 EUDAMED08806367086372 EUDAMED08806367039620 EUDAMED08806367061652 EUDAMED08806367019257 EUDAMED08806367031167 EUDAMED08806367050786 EUDAMED08806367087638 EUDAMED08806367086914 EUDAMED08806367051448 EUDAMED08806367027207 EUDAMED08806367040527 EUDAMED08806367064400 EUDAMED08806367018397 EUDAMED08809867550190 EUDAMED08806367087010 EUDAMED08806367041043 EUDAMED08806367074669 EUDAMED08806367043177 EUDAMED08806367087959 EUDAMED08806367061553 EUDAMED08806367067562 EUDAMED08806367050335 EUDAMED08806367064868 EUDAMED08806367050861 EUDAMED08806367064851 EUDAMED08806367037398 EUDAMED08806367016195 EUDAMED08806367086693 EUDAMED08806367050199 EUDAMED08806367068217 EUDAMED08806367075277 EUDAMED08806367068316 EUDAMED08806367040923 EUDAMED08806367044655 EUDAMED08806367016478 EUDAMED08806367051431 EUDAMED08806367016270 EUDAMED08806367021106 EUDAMED08806367004123 EUDAMED08806367064981 EUDAMED08806367050397 EUDAMED08806367064875 EUDAMED08806367046512 EUDAMED08806367071996 EUDAMED08806367046055 EUDAMED08806367044211 EUDAMED08806367067012 EUDAMED08806367064806 EUDAMED08806367087591 EUDAMED08806367039668 EUDAMED08806367050137 EUDAMED08806367063328 EUDAMED08806367080813 EUDAMED08806367039774 EUDAMED08806367045614 EUDAMED08806367040084 EUDAMED08806367031983 EUDAMED08806367017352 EUDAMED08806367016188 EUDAMED08806367016225 EUDAMED08806367022660 EUDAMED08806367072399 EUDAMED08806367061560 EUDAMED08806367035899 EUDAMED08806367050755 EUDAMED08806367043429 EUDAMED08806367044600 EUDAMED08806367061676 EUDAMED08806367031143 EUDAMED08806367038593 EUDAMED08809867550152 EUDAMED08806367093165 EUDAMED08806367057983 EUDAMED08806367070838 EUDAMED08806367075703 EUDAMED08806367015815 EUDAMED08806367063304 EUDAMED08806367021779 EUDAMED08806367017222 EUDAMED08806367086938 EUDAMED08806367019349 EUDAMED08806367069368 EUDAMED08806367038937 EUDAMED08806367069856 EUDAMED08806367037626 EUDAMED08806367087423 EUDAMED08806367038586 EUDAMED08806367082114 EUDAMED08806367093189 EUDAMED08806367062406 EUDAMED08806367040091 EUDAMED08806367017291 EUDAMED08809867555256 EUDAMED08806367047397 EUDAMED08806367035967 EUDAMED08806367080882 EUDAMED08806367087454 EUDAMED08806367061454 EUDAMED08806367051554 EUDAMED08806367044624 EUDAMED08806367087270 EUDAMED08806367045171 EUDAMED08806367087935 EUDAMED08806367016232 EUDAMED08806367093226 EUDAMED08806367050854 EUDAMED08806367032331 EUDAMED08806367069887 EUDAMED08806367019707 EUDAMED08806367050359 EUDAMED08806367019141 EUDAMED08806367045188 EUDAMED08806367035882 EUDAMED08806367044198 EUDAMED08806367080769 EUDAMED08806367086983 EUDAMED08806367019387 EUDAMED08806367068279 EUDAMED08806367045089 EUDAMED08806367087867 EUDAMED08806367031310 EUDAMED08806367086341 EUDAMED08806367069054 EUDAMED08806367062383 EUDAMED08806367073525 EUDAMED08806367057945 EUDAMED08806367087232 EUDAMED08806367038685 EUDAMED08806367042644 EUDAMED08806367048578 EUDAMED08806367046048 EUDAMED08806367033963 EUDAMED08806367058393 EUDAMED08806367051462 EUDAMED08806367049742 EUDAMED08806367045591 EUDAMED08806367068705 EUDAMED08806367074379 EUDAMED08806367019608 EUDAMED08806367050410 EUDAMED08806367019493 EUDAMED08806367017925 EUDAMED08806367017048 EUDAMED08806367087096 EUDAMED08806367017956 EUDAMED08806367034083 EUDAMED08806367016201 EUDAMED08806367065681 EUDAMED08806367017109 EUDAMED08806367026033 EUDAMED08809867550121 EUDAMED08806367039699 EUDAMED08806367042439 EUDAMED08806367032584 EUDAMED08806367093134 EUDAMED08806367040190 EUDAMED08806367087683 EUDAMED08806367040565 EUDAMED08806367058546 EUDAMED08806367057921 EUDAMED08806367050700 EUDAMED08806367087362 EUDAMED08806367015945 EUDAMED08806367027061 EUDAMED08806367050656 EUDAMED08806367033987 EUDAMED08806367087003 EUDAMED08806367036162 EUDAMED08806367056641 EUDAMED08806367087812 EUDAMED08806367022707 EUDAMED08806367031099 EUDAMED08806367036117 EUDAMED08809867555232 EUDAMED08806367032409 EUDAMED08806367069399 EUDAMED08806367044662 EUDAMED08806367036063 EUDAMED08806367017116 EUDAMED08806367064813 EUDAMED08806367086396 EUDAMED08806367074645 EUDAMED08806367022639 EUDAMED08806367068361 EUDAMED08806367061409 EUDAMED08806367074492 EUDAMED08809867550107 EUDAMED08806367037602 EUDAMED08806367072412 EUDAMED08806367039613 EUDAMED08806367017154 EUDAMED08806367087652 EUDAMED08806367031136 EUDAMED08806367040107 EUDAMED08806367050670 EUDAMED08806367022370 EUDAMED08806367045126 EUDAMED08806367050090 EUDAMED08806367070357 EUDAMED08806367017376 EUDAMED08806367077967 EUDAMED08806367017246 EUDAMED08806367050663 EUDAMED08806367036568 EUDAMED08806367048561 EUDAMED08806367058485 EUDAMED08806367058355 EUDAMED08806367046062 EUDAMED08806367069139 EUDAMED08806367050892 EUDAMED08806367042262 EUDAMED08806367031501 EUDAMED08806367032188 EUDAMED08806367016713 EUDAMED08806367079602 EUDAMEDFDA UDI08806367047052 EUDAMEDFDA UDI08806367017581 EUDAMEDFDA UDI08806367080783 EUDAMEDFDA UDI08806367047069 EUDAMEDFDA UDI08806367039484 EUDAMEDFDA UDI08806367020352 EUDAMEDFDA UDI08806367047199 EUDAMEDFDA UDI08806367039743 EUDAMEDFDA UDI08806367064431 EUDAMED08806367047809 EUDAMED08806367071347 EUDAMED08806367017215 EUDAMED08806367017314 EUDAMED08806367033017 EUDAMED08806367070715 EUDAMED08806367046628 EUDAMED08806367050298 EUDAMED08806367032539 EUDAMED08806367015983 EUDAMED08806367045904 EUDAMED08806367061638 EUDAMED08806367072023 EUDAMED08806367061546 EUDAMED08806367040411 EUDAMED08806367027047 EUDAMED08806367092540 EUDAMED08806367016669 EUDAMED08806367037671 EUDAMED08806367017086 EUDAMED08806367087027 EUDAMED08806367044068 EUDAMED08806367038661 EUDAMED08806367032386 EUDAMED08806367050373 EUDAMED08806367036247 EUDAMED08806367035974 EUDAMED08806367016171 EUDAMED08806367004406 EUDAMED08806367022653 EUDAMED08806367050687 EUDAMED08806367022677 EUDAMED08806367040930 EUDAMED08806367057914 EUDAMED08806367047823 EUDAMED08806367016461 EUDAMED08806367071330 EUDAMED08806367068187 EUDAMED08806367066428 EUDAMED08806367050250 EUDAMED08806367061522 EUDAMED08806367020918 EUDAMED08806367037657 EUDAMED08806367058423 EUDAMED08806367073501 EUDAMED08806367016683 EUDAMED08806367057228 EUDAMED08806367070067 EUDAMED08806367082947 EUDAMED08806367035905 EUDAMED08806367037664 EUDAMED08806367039521 EUDAMED08806367067128 EUDAMED08806367066398 EUDAMED08806367062420 EUDAMED08806367087072 EUDAMED08806367019592 EUDAMED08806367045997 EUDAMED08806367068231 EUDAMED08806367031150 EUDAMED08806367088895 FDA UDI08806367088741 FDA UDI
- Basic UDI-DI
- B-08806367093233 EUDAMEDB-08806367050779 EUDAMEDB-08806367021786 EUDAMEDB-08806367087089 EUDAMEDB-08806367086266 EUDAMEDB-08806367068910 EUDAMEDB-08806367063281 EUDAMEDB-08806367063298 EUDAMEDB-08806367038357 EUDAMEDB-08806367074089 EUDAMEDB-08806367017819 EUDAMEDB-08806367035936 EUDAMEDB-08806367016218 EUDAMEDB-08806367040114 EUDAMEDB-08806367044327 EUDAMEDB-08806367086280 EUDAMEDB-08806367024886 EUDAMEDB-08806367050922 EUDAMEDB-08806367047236 EUDAMEDB-08806367045119 EUDAMEDB-08806367016249 EUDAMEDB-08806367061461 EUDAMEDB-08806367068323 EUDAMEDB-08806367077868 EUDAMEDB-08806367031303 EUDAMEDB-08806367044594 EUDAMEDB-08806367087256 EUDAMEDB-08806367039651 EUDAMEDB-08806367037619 EUDAMEDB-08806367067524 EUDAMEDB-08806367087430 EUDAMEDB-08806367086877 EUDAMEDB-08809867550183 EUDAMEDB-08806367049193 EUDAMEDB-08806367017024 EUDAMEDB-08809867550138 EUDAMEDB-08806367022837 EUDAMEDB-08806367035875 EUDAMEDB-08806367072368 EUDAMEDB-08806367026293 EUDAMEDB-08806367058577 EUDAMEDB-08806367039507 EUDAMEDB-08806367058454 EUDAMEDB-08806367016256 EUDAMEDB-08806367026255 EUDAMEDB-08806367023971 EUDAMEDB-08806367087690 EUDAMEDB-08806367044006 EUDAMEDB-08806367086891 EUDAMEDB-08806367037411 EUDAMEDB-08806367087492 EUDAMEDB-08806367016706 EUDAMEDB-08806367046116 EUDAMEDB-08806367040893 EUDAMEDB-08806367030122 EUDAMEDB-08806367035929 EUDAMEDB-08806367074706 EUDAMEDB-08806367019486 EUDAMEDB-08806367071958 EUDAMEDB-08806367029614 EUDAMEDB-08806367087041 EUDAMEDB-08806367017239 EUDAMEDB-08806367047403 EUDAMEDB-08806367058430 EUDAMEDB-08806367086303 EUDAMEDB-08806367049803 EUDAMEDB-08806367044808 EUDAMEDB-08806367023483 EUDAMEDB-08806367033949 EUDAMEDB-08806367086518 EUDAMEDB-08806367040459 EUDAMEDB-08806367036100 EUDAMEDB-08806367062369 EUDAMEDB-08806367004390 EUDAMEDB-08806367093172 EUDAMEDB-08806367075666 EUDAMEDB-08806367049452 EUDAMEDB-08806367061478 EUDAMEDB-08806367086242 EUDAMEDB-08809867550176 EUDAMEDB-08809867555249 EUDAMEDB-08806367039644 EUDAMEDB-08806367039514 EUDAMEDB-08806367061539 EUDAMEDB-08806367032577 EUDAMEDB-08806367093219 EUDAMEDB-08806367068347 EUDAMEDB-08806367068804 EUDAMEDB-08806367047410 EUDAMEDB-08806367064844 EUDAMEDB-08806367030863 EUDAMEDB-08806367068866 EUDAMEDB-08806367017857 EUDAMEDB-08806367073938 EUDAMEDB-08806367033840 EUDAMEDB-08806367045133 EUDAMEDB-08806367061867 EUDAMEDB-08806367019394 EUDAMEDB-08806367074270 EUDAMEDB-08806367068828 EUDAMEDB-08806367027030 EUDAMEDB-08806367004116 EUDAMEDB-08806367046529 EUDAMEDB-08806367051486 EUDAMEDB-08806367080691 EUDAMEDB-08806367074539 EUDAMEDB-08806367086747 EUDAMEDB-08806367029546 EUDAMEDB-08806367035950 EUDAMEDB-08806367017338 EUDAMEDB-08806367071965 EUDAMEDB-08806367058515 EUDAMEDB-08806367027023 EUDAMEDB-08806367093196 EUDAMEDB-08806367077783 EUDAMEDB-08806367069382 EUDAMEDB-08806367073488 EUDAMEDB-08806367064998 EUDAMEDB-08806367087324 EUDAMEDB-08806367051400 EUDAMEDB-08806367050144 EUDAMEDB-08806367086570 EUDAMEDB-08806367036612 EUDAMEDB-08806367037213 EUDAMEDB-08806367026286 EUDAMEDB-08806367051424 EUDAMEDB-08806367048110 EUDAMEDB-08806367087065 EUDAMEDB-08806367019226 EUDAMEDB-08806367086969 EUDAMEDB-08806367031129 EUDAMEDB-08806367063250 EUDAMEDB-08806367020956 EUDAMEDB-08806367064387 EUDAMEDB-08806367075260 EUDAMEDB-08806367040466 EUDAMEDB-08806367087478 EUDAMEDB-08806367066947 EUDAMEDB-08806367017208 EUDAMEDB-08806367086419 EUDAMEDB-08806367086372 EUDAMEDB-08806367039620 EUDAMEDB-08806367061652 EUDAMEDB-08806367019257 EUDAMEDB-08806367031167 EUDAMEDB-08806367050786 EUDAMEDB-08806367087638 EUDAMEDB-08806367086914 EUDAMEDB-08806367051448 EUDAMEDB-08806367027207 EUDAMEDB-08806367040527 EUDAMEDB-08806367064400 EUDAMEDB-08806367018397 EUDAMEDB-08809867550190 EUDAMEDB-08806367087010 EUDAMEDB-08806367041043 EUDAMEDB-08806367074669 EUDAMEDB-08806367043177 EUDAMEDB-08806367087959 EUDAMEDB-08806367061553 EUDAMEDB-08806367067562 EUDAMEDB-08806367050335 EUDAMEDB-08806367064868 EUDAMEDB-08806367050861 EUDAMEDB-08806367064851 EUDAMEDB-08806367037398 EUDAMEDB-08806367016195 EUDAMEDB-08806367086693 EUDAMEDB-08806367050199 EUDAMEDB-08806367068217 EUDAMEDB-08806367075277 EUDAMEDB-08806367068316 EUDAMEDB-08806367040923 EUDAMEDB-08806367044655 EUDAMEDB-08806367016478 EUDAMEDB-08806367051431 EUDAMEDB-08806367016270 EUDAMEDB-08806367021106 EUDAMEDB-08806367004123 EUDAMEDB-08806367064981 EUDAMEDB-08806367050397 EUDAMEDB-08806367064875 EUDAMEDB-08806367046512 EUDAMEDB-08806367071996 EUDAMEDB-08806367046055 EUDAMEDB-08806367044211 EUDAMEDB-08806367067012 EUDAMEDB-08806367064806 EUDAMEDB-08806367087591 EUDAMEDB-08806367039668 EUDAMEDB-08806367050137 EUDAMEDB-08806367063328 EUDAMEDB-08806367080813 EUDAMEDB-08806367039774 EUDAMEDB-08806367045614 EUDAMEDB-08806367040084 EUDAMEDB-08806367031983 EUDAMEDB-08806367017352 EUDAMEDB-08806367016188 EUDAMEDB-08806367016225 EUDAMEDB-08806367022660 EUDAMEDB-08806367072399 EUDAMEDB-08806367061560 EUDAMEDB-08806367035899 EUDAMEDB-08806367050755 EUDAMEDB-08806367043429 EUDAMEDB-08806367044600 EUDAMEDB-08806367061676 EUDAMEDB-08806367031143 EUDAMEDB-08806367038593 EUDAMEDB-08809867550152 EUDAMEDB-08806367093165 EUDAMEDB-08806367057983 EUDAMEDB-08806367070838 EUDAMEDB-08806367075703 EUDAMEDB-08806367015815 EUDAMEDB-08806367063304 EUDAMEDB-08806367021779 EUDAMEDB-08806367017222 EUDAMEDB-08806367086938 EUDAMEDB-08806367019349 EUDAMEDB-08806367069368 EUDAMEDB-08806367038937 EUDAMEDB-08806367069856 EUDAMEDB-08806367037626 EUDAMEDB-08806367087423 EUDAMEDB-08806367038586 EUDAMEDB-08806367082114 EUDAMEDB-08806367093189 EUDAMEDB-08806367062406 EUDAMEDB-08806367040091 EUDAMEDB-08806367017291 EUDAMEDB-08809867555256 EUDAMEDB-08806367047397 EUDAMEDB-08806367035967 EUDAMEDB-08806367080882 EUDAMEDB-08806367087454 EUDAMEDB-08806367061454 EUDAMEDB-08806367051554 EUDAMEDB-08806367044624 EUDAMEDB-08806367087270 EUDAMEDB-08806367045171 EUDAMEDB-08806367087935 EUDAMEDB-08806367016232 EUDAMEDB-08806367093226 EUDAMEDB-08806367050854 EUDAMEDB-08806367032331 EUDAMEDB-08806367069887 EUDAMEDB-08806367019707 EUDAMEDB-08806367050359 EUDAMEDB-08806367019141 EUDAMEDB-08806367045188 EUDAMEDB-08806367035882 EUDAMEDB-08806367044198 EUDAMEDB-08806367080769 EUDAMEDB-08806367086983 EUDAMEDB-08806367019387 EUDAMEDB-08806367068279 EUDAMEDB-08806367045089 EUDAMEDB-08806367087867 EUDAMEDB-08806367031310 EUDAMEDB-08806367086341 EUDAMEDB-08806367069054 EUDAMEDB-08806367062383 EUDAMEDB-08806367073525 EUDAMEDB-08806367057945 EUDAMEDB-08806367087232 EUDAMEDB-08806367038685 EUDAMEDB-08806367042644 EUDAMEDB-08806367048578 EUDAMEDB-08806367046048 EUDAMEDB-08806367033963 EUDAMEDB-08806367058393 EUDAMEDB-08806367051462 EUDAMEDB-08806367049742 EUDAMEDB-08806367045591 EUDAMEDB-08806367068705 EUDAMEDB-08806367074379 EUDAMEDB-08806367019608 EUDAMEDB-08806367050410 EUDAMEDB-08806367019493 EUDAMEDB-08806367017925 EUDAMEDB-08806367017048 EUDAMEDB-08806367087096 EUDAMEDB-08806367017956 EUDAMEDB-08806367034083 EUDAMEDB-08806367016201 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- 510(k) Number
- K200860 FDA UDIK201342 FDA UDIK111149 FDA UDIK201160 FDA UDIK183616 FDA UDIK213251 FDA UDI
- FDA Product Code
- ESW FDA UDIJCT FDA UDIFGE FDA UDIMQR FDA UDI
- EMDN Code
- K0201010301,P0502 EUDAMEDP0503 COLONIC AND DUODENAL PROSTHESES EUDAMEDP050101 GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES EUDAMEDP0502 BILIARY AND PANCREATIC PROSTHESES EUDAMEDP050199 ESOPHAGEAL PROSTHESES - OTHER EUDAMEDP0401 TRACHEOBRONCHIAL PROSTHESES EUDAMED
- GMDN Term
- Polymer-metal oesophageal stent FDA UDIPolymer-metal tracheal/bronchial stent FDA UDIBare-metal biliary stent FDA UDIBare-metal colonic stent FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3610 FDA UDI878.3720 FDA UDI876.5010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Stent Diameter — 20 Millimeter FDA UDIStent Length — 100 Millimeter FDA UDIStent Diameter — 12 Millimeter FDA UDIStent Length — 20 Millimeter FDA UDILength — 50 Millimeter FDA UDILumen/Inner Diameter — 08 Millimeter FDA UDIStent Diameter — 18 Millimeter FDA UDIStent Length — 140 Millimeter FDA UDILength — 60 Millimeter FDA UDILumen/Inner Diameter — 10 Millimeter FDA UDILength — 2300 Millimeter FDA UDIStent Length — 120 Millimeter FDA UDIStent Diameter — 22 Millimeter FDA UDIStent Length — 80 Millimeter FDA UDIStent Length — 90 Millimeter FDA UDILength — 120 Millimeter FDA UDIStent Length — 130 Millimeter FDA UDI
The Pancreatic Drainage Stent with Electrocautery Delivery System is a self-expanding metallic stent (nomenclature codes K0201010301, P0502) designed for internal biliary or pancreatic duct drainage. It combines mechanical support with an integrated electrocautery mechanism to facilitate precise placement and sealing within obstructed ducts, reducing the risk of leakage or migration. The device is implanted and sterile, intended for use in endoscopic procedures where traditional stents may fail due to strictures or high-pressure leaks.
This stent is single-use and supplied sterile, requiring no reprocessing. It is MRI-unsafe due to its metallic construction and active electrocautery components, necessitating caution in imaging environments. Available in the specified Model BCF-16-040-T140, it adheres to FDA 510(k) and MDD regulatory standards. Storage must comply with manufacturer guidelines to preserve sterility and functionality prior to use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093537 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K253327 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K072094 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K111149 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08806367093233 | Class IIb | Active |
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Manufacturer
- Manufacturer
- M.I.Tech Co., Ltd
- EUDAMED SRN
- KR-MF-000011623
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (437)
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