Identity
- Trade Name
- CODMAN UNI-SHUNT FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- CODMAN UNI-SHUNT With Reservoir Kit Shunt 62cm Long Low Closing Pressure 2-5cm H2O Contents: One-Piece Barium Shunt with Reservoir (1), 17 Gauge Blunt Tip Needle (1), Anchoring Clips (2), Disposable Introducer (1), 36cm Disposable Catheter Passer (1) (196Pa - 490Pa) FDA UDI
- Model / Reference
- 82-8511 FDA UDI
- Description
- CODMAN UNI-SHUNT With Reservoir Kit Shunt 62cm Long Low Closing Pressure 2-5cm H2O Contents: One-Piece Barium Shunt with Reservoir (1), 17 Gauge Blunt Tip Needle (1), Anchoring Clips (2), Disposable Introducer (1), 36cm Disposable Catheter Passer (1) (196Pa - 490Pa) FDA UDI
Identifiers
- Catalog Number
- 828511 FDA UDI
- Primary DI / UDI-DI
- 10886704042549 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculoperitoneal shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Codman Uni-Shunt by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cerenovus, Inc.
Sources (1)
- FDA UDI 139e433e-9369-460e-a590-64d607878386 36 fields · synced May 31, 2026