Identity
- Trade Name
- CODMAN® BACTISEAL® FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, short-term FDA UDI
- Device Name
- BEVC KIT BACTISEAL® Endoscopic Ventricular Catheter and Distal Catheter Kit MR Conditional Contents: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Right Angle Adapter (1) FDA UDI
- Model / Reference
- 823088 FDA UDI
- Description
- BEVC KIT BACTISEAL® Endoscopic Ventricular Catheter and Distal Catheter Kit MR Conditional Contents: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Right Angle Adapter (1) FDA UDI
Identifiers
- Catalog Number
- 82-3088 FDA UDI
- Primary DI / UDI-DI
- 10381780537045 FDA UDI
- FDA Product Code
- HCA FDA UDIJXG FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4100 FDA UDI882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
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
Dimensions & Sizes
- Size
- Catheter Length — 14 Centimeter FDA UDICatheter Length — 120 Centimeter FDA UDI
Category: Intracerebral infusion/drainage catheter, short-term
Codman® Bactiseal® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 9d375f0d-68a7-4576-9aaa-749d94cfeb7c 37 fields · synced Jun 9, 2026