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PULL THRU™ Cleaning Brush
EUDAMEDFDA UDIClass I (EU MDR)
Ref ZZ0112+1+SPUP+1100/NSModel PULL THRU™ Cleaning BrushRef ZZ2848+1+SPUP+2500/NSRef ZZ1317+180+0+2200Ref ZZ0112+1+SPUP+2200Model Single Patient Use PackRef PD2642Ref SP2848+3+0+2200Ref ZZ0112+1+20SPUP+2200/NSRef PD2850Ref ZZ1426+1+SPUP+2200/NSRef ZZ0608+60+0+1290Ref ZZ2848+180+0+2200Ref ZZ1317+60+0+2200Ref ZZ0608+1+SPUP+1290/NSRef ZZ0112+360+0+2200Ref ZZ2642+60+0+2200Ref ZZ2850+180+0+2500Ref SP1426+3+0+2200Ref ZZ1317+1+SPUP+2200/NSRef ZZ1426+1+SPUP+750/NSRef ZZ0112+180+0+750Ref ZZ1426+1+SPUP+1200Ref ZZ2850+1+SPUP+2500Ref ZZ2642+180+0+2200Ref ZZ0608+60+NC+1290Ref ZZ1426+1+SPUP+750Ref ZZ0112+1+SPUP+1100Ref ZZ2850+180+0+1600Ref ZZ0112+1+SPUP+2200/NSRef ZZ1317+1+SPUP+1100Ref ZZ2848+240+0+2200Ref ZZ2642+1+SPUP+2200Ref ZZ1317+1+SPUP+2200Ref ZZ2848+1+SPUP+2500Ref SPCSD+6+610Ref ZZ1426+1+SPUP+2500/NSRef SP0112+3+0+2200Ref ZZ2848+1+SPUP+2200Ref ZZ1317+60+NC+2200Ref SP2850+3+0+2200Ref ZZ1317+180+0+1100Ref ZZ2642+60+NC+2200Ref ZZ2642+240+0+2200Ref ZZ1426+2400+0+2200Ref ZZ2850+1+SPUP+2500/NS
Identity
- Trade Name
- PULL THRU™ Cleaning Brush EUDAMEDFDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- 1 x Channel cleaning brush, channel ID 1.0-1.2mm, length 2200mm, 3 x 360 degree wipers. 1 x Port cleaning brush, double head, 5mm and 12mm. FDA UDI
- Model / Reference
- PULL THRU™ Cleaning Brush EUDAMEDZZ0112+1+SPUP+1100/NS EUDAMEDZZ2848+1+SPUP+2500/NS EUDAMEDZZ1317+180+0+2200 EUDAMEDSingle Patient Use Pack EUDAMEDZZ0112+1+SPUP+2200 EUDAMEDPD2642 EUDAMEDSP2848+3+0+2200 EUDAMEDZZ0112+1+20SPUP+2200/NS EUDAMEDPD2850 EUDAMEDZZ1426+1+SPUP+2200/NS EUDAMEDZZ0608+60+0+1290 EUDAMEDZZ2848+180+0+2200 EUDAMEDZZ1317+60+0+2200 EUDAMEDZZ0608+1+SPUP+1290/NS EUDAMEDZZ0112+360+0+2200 EUDAMEDZZ2642+60+0+2200 EUDAMEDZZ2850+180+0+2500 EUDAMEDSP1426+3+0+2200 EUDAMEDZZ1317+1+SPUP+2200/NS EUDAMEDZZ1426+1+SPUP+750/NS EUDAMEDZZ0112+180+0+750 EUDAMEDZZ1426+1+SPUP+1200 EUDAMEDZZ2850+1+SPUP+2500 EUDAMEDZZ2642+180+0+2200 EUDAMEDZZ0608+60+NC+1290 EUDAMEDZZ1426+1+SPUP+750 EUDAMEDZZ0112+1+SPUP+1100 EUDAMEDZZ2850+180+0+1600 EUDAMEDZZ0112+1+SPUP+2200/NS EUDAMEDZZ1317+1+SPUP+1100 EUDAMEDZZ2848+240+0+2200 EUDAMEDZZ2642+1+SPUP+2200 EUDAMEDZZ1317+1+SPUP+2200 EUDAMEDZZ2848+1+SPUP+2500 EUDAMEDSPCSD+6+610 EUDAMEDZZ1426+1+SPUP+2500/NS EUDAMEDSP0112+3+0+2200 EUDAMEDZZ2848+1+SPUP+2200 EUDAMEDZZ1317+60+NC+2200 EUDAMEDSP2850+3+0+2200 EUDAMEDZZ1317+180+0+1100 EUDAMEDZZ2642+60+NC+2200 EUDAMEDZZ2642+240+0+2200 EUDAMEDZZ1426+2400+0+2200 EUDAMEDZZ2850+1+SPUP+2500/NS EUDAMEDZZ0112+1+SPUP+2200 Single patient pack FDA UDI
- Description
- 1 x Channel cleaning brush, channel ID 1.0-1.2mm, length 2200mm, 3 x 360 degree wipers. 1 x Port cleaning brush, double head, 5mm and 12mm. FDA UDI
Identifiers
- Catalog Number
- ZZ0112+1+SPUP+2200 FDA UDI
- Primary DI / UDI-DI
- 09421028491563 EUDAMED09421028492911 EUDAMED09421028493017 EUDAMED09421028490672 EUDAMEDFDA UDI09421028492492 EUDAMED09421028491105 EUDAMED09421028490061 EUDAMED09421028493062 EUDAMED09421028491860 EUDAMED09421028491785 EUDAMED09421028491013 EUDAMED09421028493611 EUDAMED09421028492546 EUDAMED09421028492263 EUDAMED09421028492867 EUDAMED09421028492454 EUDAMED09421028490740 EUDAMED09421028490610 EUDAMED09421028490450 EUDAMED09421028491907 EUDAMED09421028491839 EUDAMED09421028490979 EUDAMED09421028492034 EUDAMED09421028493543 EUDAMED09421028490030 EUDAMED09421028493635 EUDAMED09421028492379 EUDAMED09421028491334 EUDAMED09421028492409 EUDAMED09421028492096 EUDAMED09421028492058 EUDAMED09421028492003 EUDAMED09421028492577 EUDAMED09421028493178 EUDAMED09421028493581 EUDAMED09421028490719 EUDAMED09421028490986 EUDAMED09421028490658 EUDAMED09421028491723 EUDAMED09421028492188 EUDAMED09421028492959 EUDAMED09421028493529 EUDAMED09421028493567 EUDAMED09421028491532 EUDAMED
- Basic UDI-DI
- 942102849MDCCB8G EUDAMED942102849MDCCBPPFU EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070101 ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE EUDAMED
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Medical Purpose
- The contents of the procedure pack are single use brushes intended for the manual cleaning of endoscopes and other medical instruments which may have internal channels. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PULL THRU™ Cleaning Brush by F.r.galantai Manufacturing Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942102849MDCCB8G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- F R Galantai Manufacturing Company Limited
- EUDAMED SRN
- NZ-MF-000002767
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (45)
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