Identity
- Trade Name
- CODMAN® HOLTER® FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, long-term FDA UDI
- Device Name
- CODMAN® HOLTER® Ventricular Catheter 3cm FDA UDI
- Model / Reference
- 821652 FDA UDI
- Description
- CODMAN® HOLTER® Ventricular Catheter 3cm FDA UDI
Identifiers
- Catalog Number
- 82-1652 FDA UDI
- Primary DI / UDI-DI
- 10381780517894 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, long-term 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
Dimensions & Sizes
- Size
- Length — 3 Centimeter FDA UDI
Category: Intracerebral infusion/drainage catheter, long-term
Codman® Holter® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral infusion/drainage catheter, long-term.
- BioGlide® — Medtronic PS Medical · Class II
- Phoenix Neuro — Sophysa SA · Class II
- Innervision, BioGlide® — Medtronic PS Medical · Class II
- Natus® — Natus Medical Incorporated · Class II
- Phoenix Neuro — Sophysa SA · Class II
- Innervision — Medtronic PS Medical · Class II
- Natus® — Natus Medical Incorporated · Class II
- Phoenix Neuro — Sophysa SA · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 9644292c-1c8b-4a86-be55-320bedac0a43 36 fields · synced Jun 9, 2026