Identity
- Trade Name
- OSV II® FDA UDI
- Generic Name
- Ventriculo-peritoneal/atrial shunt FDA UDI
- Device Name
- Valve System WITH ANTECHAMBER, SEPARATE 15 CM VENTRICULAR CATHETER & 65 CM MALLEABLE TUNNELER FLOW REGULATION* : 18 - 30 ml/hr For ventricular shunting of cerebrospinal fluid. FDA UDI
- Model / Reference
- 909714 FDA UDI
- Description
- Valve System WITH ANTECHAMBER, SEPARATE 15 CM VENTRICULAR CATHETER & 65 CM MALLEABLE TUNNELER FLOW REGULATION* : 18 - 30 ml/hr For ventricular shunting of cerebrospinal fluid. FDA UDI
Identifiers
- Catalog Number
- 909714 FDA UDI
- Primary DI / UDI-DI
- 10381780034056 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculo-peritoneal/atrial 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
Yes
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
MR Conditional FDA UDI
Osv Ii® by Integra LifeSciences Switzerland Sàrl — 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 |
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Manufacturer
- Manufacturer
- Integra LifeSciences Switzerland Sàrl
Sources (1)
- FDA UDI 930b72c3-3541-4ecf-9364-3ddb1fb711e0 38 fields · synced Jun 6, 2026