Identity
- Trade Name
- Silicone Biliary Stent FDA UDI
- Generic Name
- Biliary drain FDA UDI
- Model / Reference
- GR83064-02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00684995500037 FDA UDI
- 510(k) Number
- K844384 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Biliary drain 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
No
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: Biliary drain
Silicone Biliary Stent by Bentec Medical OpCo, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K844384 also covers:
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
- Silicone Biliary Stent — Bentec Medical OpCo, LLC.
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
- Bentec Medical OpCo, LLC.
Sources (1)
- FDA UDI bfa23cb0-517e-4b3f-8421-2aaea2f6ca95 33 fields · synced May 30, 2026