Identity
- Trade Name
- OSV II® FDA UDI
- Generic Name
- Lumboperitoneal shunt FDA UDI
- Device Name
- OSV II® Lumbar Valve System FDA UDI
- Model / Reference
- 909711 FDA UDI
- Description
- OSV II® Lumbar Valve System FDA UDI
Identifiers
- Catalog Number
- 909711 FDA UDI
- Primary DI / UDI-DI
- 10381780034025 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Lumboperitoneal shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Lumboperitoneal shunt
Osv Ii® by Integra LifeSciences Switzerland Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumboperitoneal shunt.
- GAV 2.0 — AESCULAP, INC. · Class II
- Integra Spetzler™ Lumbar Peritoneal Shunt System — Integra Lifesciences Corp. · Class II
- SHUNTASSISTANT 2.0 — AESCULAP, INC. · Class II
- Natus® — Natus Medical Incorporated · Class II
- SHUNTASSISTANT 2.0 — AESCULAP, INC. · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HOLTER® — Integra LifeSciences Production Corporation · Class II
- Strata™ — Medtronic PS Medical · Class II
Cleared under the same submission
K092395 also covers:
K140722 also covers:
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 68511181-6f71-476f-9a4d-2f74b10ef191 38 fields · synced May 30, 2026