Identity
- Trade Name
- CODMAN® HOLTER® FDA UDI
- Generic Name
- Lumboperitoneal shunt FDA UDI
- Device Name
- CODMAN® HOLTER® Lumbo-Peritoneal Shunt, Hoffman Design 3.6mm FDA UDI
- Model / Reference
- 821698 FDA UDI
- Description
- CODMAN® HOLTER® Lumbo-Peritoneal Shunt, Hoffman Design 3.6mm FDA UDI
Identifiers
- Catalog Number
- 82-1698 FDA UDI
- Primary DI / UDI-DI
- 10381780540748 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
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
Yes
FDA UDI
Category: Lumboperitoneal shunt
Codman® Holter® by Integra LifeSciences Production Corporation — 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
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- Natus® — Natus Medical Incorporated · Class II
- SHUNTASSISTANT 2.0 — AESCULAP, INC. · Class II
- Strata™ — Medtronic PS Medical · Class II
- GAV 2.0 — AESCULAP, INC. · Class II
- Strata® — Medtronic PS Medical · 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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI d7cacf4f-be03-41ac-9eca-e10ca539f5b9 36 fields · synced Jun 9, 2026