Identity
- Trade Name
- Geenen FDA UDI
- Generic Name
- Polymeric pancreatic stent, non-bioabsorbable FDA UDI
- Device Name
- Geenen Pancreatic Stent FDA UDI
- Model / Reference
- G21379 FDA UDI
- Description
- Geenen Pancreatic Stent FDA UDI
Identifiers
- Catalog Number
- GPSO-7-9 FDA UDI
- Primary DI / UDI-DI
- 00827002213791 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Polymeric pancreatic 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 pancreatic stent, non-bioabsorbable
Geenen Pancreatic Stent is a unique, non-bioabsorbable tubular device designed to provide temporary drainage of the pancreatic duct for patients with obstructed pancreatic ducts. Its sterile design and synthetic polymer material make it an ideal choice for complex endoscopic procedures.
Similar devices
Also classified as Polymeric pancreatic stent, non-bioabsorbable.
- PANCREATIC STENT — Olympus Medical Systems Corporation · Class II
- Advanix™ Pancreatic Stent — Boston Scientific · Class II
- Advanix™ Pancreatic Stent — Boston Scientific · Class II
- Advanix™ Pancreatic Stent — Boston Scientific · Class II
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC. · Class II
- Freeman Pancreatic Flexi-Stent Kit — HOBBS MEDICAL, INC. · Class II
- Advanix™ Pancreatic Stent — Boston Scientific · Class II
- Advanix™ Pancreatic Stent — 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 7c2f8f8e-d759-4bd0-b553-0f8333c5ebe8 36 fields · synced Jul 13, 2026