Identity
- Trade Name
- Zimmon FDA UDI
- Generic Name
- Polymeric biliary stent, non-bioabsorbable FDA UDI
- Device Name
- Zimmon, Biliary Stent Set FDA UDI
- Model / Reference
- G21789 FDA UDI
- Description
- Zimmon, Biliary Stent Set FDA UDI
Identifiers
- Catalog Number
- ZEBD-10-9 FDA UDI
- Primary DI / UDI-DI
- 00827002217898 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Polymeric biliary stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA 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
Yes
FDA UDI
Category: Polymeric biliary stent, non-bioabsorbable
Zimmon by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric biliary stent, non-bioabsorbable.
- RX Biliary — Boston Scientific · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
- Advanix™ Biliary — Boston Scientific · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
- Advanix™ Biliary — Boston Scientific · Class II
- Advanix™ Biliary — Boston Scientific · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA UDI aa7d2824-5856-43c8-a185-2967bcb9dc38 36 fields · synced May 30, 2026