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FibriJet
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref 800-0251Ref SA-3667Ref SA-3620Ref SA-3310Ref SA-3662510(k) K042834Ref SA-3600Ref SA-4460Ref SA-3660Ref SA-4400Ref SA-3671-100
Identity
- Trade Name
- FibriJet EUDAMEDFDA UDINordson Medical FDA UDI
- Generic Name
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
- Device Name
- RATIO PROCEDURE KIT EUDAMEDEndoscopic Applicator With Mixing Tip EUDAMEDAPPLICATOR TIP EUDAMEDAPPLICATOR ASSEMBLY EUDAMEDDUAL SPRAY PROCEDURE KIT EUDAMEDFDA UDISingle Spray Tip EUDAMEDMANUAL ENDOSCOPIC SPRAY APP.W/MIX TIP 5MM X 30CM, 1:1 RATIO FDA UDI
- Model / Reference
- 800-0251 EUDAMEDSA-3667 EUDAMEDSA-3620 EUDAMEDSA-3310 EUDAMEDSA-3662 EUDAMEDFDA UDISA-4460 EUDAMEDFDA UDISA-3600 EUDAMEDSA-3660 EUDAMEDSA-4400 EUDAMEDSA-3671-100 EUDAMED
- Description
- DUAL SPRAY PROCEDURE KIT FDA UDIMANUAL ENDOSCOPIC SPRAY APP.W/MIX TIP 5MM X 30CM, 1:1 RATIO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815634021744 EUDAMED10815634020181 EUDAMED10815634021584 EUDAMED10815634020969 EUDAMED10815634020068 EUDAMED00815634020887 EUDAMEDFDA UDI00815634020061 EUDAMEDFDA UDI10815634021546 EUDAMED10815634020778 EUDAMED10815634020884 EUDAMED10815634020877 EUDAMED10815634021683 EUDAMED
- Basic UDI-DI
- B-10815634021744 EUDAMEDB-10815634020181 EUDAMEDB-10815634021584 EUDAMEDB-10815634020969 EUDAMEDB-10815634020068 EUDAMEDB-10815634021546 EUDAMEDB-00815634020887 EUDAMEDB-10815634020778 EUDAMEDB-10815634020884 EUDAMEDB-00815634020061 EUDAMEDB-10815634020877 EUDAMEDB-10815634021683 EUDAMED
- 510(k) Number
- FDA Product Code
- GCJ FDA 510(k)FDA UDIFMF FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)FDA UDI880.5860 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FibriJet by Micromedics, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042834 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-10815634021744 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (15)
- EUDAMED 8688c0cc-eb9f-486d-8bf3-385e5c1faa80 61 fields · synced Aug 4, 2026
- EUDAMED 45f45dba-d0eb-4d5d-a47d-bfc89bb887f9 61 fields · synced May 16, 2026
- EUDAMED c036e98e-3ca3-409f-bcc4-591edbd03fd2 61 fields · synced May 17, 2026
- EUDAMED 980461a4-6a14-46ce-961e-ed475d096610 61 fields · synced May 17, 2026
- EUDAMED 0913db76-db8b-4121-8e74-4c88ead4302c 61 fields · synced May 17, 2026
- FDA 510(k) K042834 24 fields · synced May 18, 2026
- FDA UDI 91625a9f-f5d2-4cda-b073-b0f923be97cc 33 fields · synced May 30, 2026
- FDA UDI 8a206a43-1d6a-4894-ad23-d77b3a7120d2 34 fields · synced May 30, 2026
- EUDAMED b5f3adfe-ac3a-4ff0-97fb-07158fec917c 61 fields · synced Jul 9, 2026
- EUDAMED ae5dc852-d888-4f97-b022-ec469d61048a 61 fields · synced Jul 9, 2026
- EUDAMED 8f7a64a3-1187-449c-bf3b-0af7e65caea0 61 fields · synced Jul 14, 2026
- EUDAMED c6b60ebc-efb7-400f-9010-fd40f6a71ddd 61 fields · synced Jul 14, 2026
- EUDAMED 2d4e820c-2872-47f2-ad85-2e445a136171 61 fields · synced Jul 16, 2026
- EUDAMED e461102b-d87e-4355-b9f7-fa8a5a5d7614 61 fields · synced Jul 17, 2026
- EUDAMED d400b9c2-8763-4cfd-bbd8-53650eba6aa9 61 fields · synced Aug 4, 2026