Identity
- Trade Name
- CODMAN® BACTISEAL® FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, long-term FDA UDI
- Device Name
- CODMAN® BACTISEAL® Programmable Cylindrical Valve with Rickham Reservoir and Unitized SIPHONGUARD' Device and Distal Catheter Programmable in steps of 10mnm H2O (98 Pa) 30mm H2O to 200mm H2O (294Pa. 1900Pa) Includes 120cm Distal Length including SIPHONGUA FDA UDI
- Model / Reference
- NS0343 FDA UDI
- Description
- CODMAN® BACTISEAL® Programmable Cylindrical Valve with Rickham Reservoir and Unitized SIPHONGUARD' Device and Distal Catheter Programmable in steps of 10mnm H2O (98 Pa) 30mm H2O to 200mm H2O (294Pa. 1900Pa) Includes 120cm Distal Length including SIPHONGUA FDA UDI
Identifiers
- Catalog Number
- NS0343 FDA UDI
- Primary DI / UDI-DI
- 10381780524083 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
No
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 — 23 Centimeter FDA UDI
Category: Intracerebral infusion/drainage catheter, long-term
Codman® Bactiseal® 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 5b6b9644-b494-42c1-9068-3d9cba084aca 37 fields · synced Jun 9, 2026