Identity
- Trade Name
- CODMAN® BACTISEAL® FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, short-term FDA UDI
- Device Name
- CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1), Connector (1), Cap (1), Catheter Anchoring Clip (1); Additional Contents: Trocar (1), Stylet (1) FDA UDI
- Model / Reference
- 821745 FDA UDI
- Description
- CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1), Connector (1), Cap (1), Catheter Anchoring Clip (1); Additional Contents: Trocar (1), Stylet (1) FDA UDI
Identifiers
- Catalog Number
- 82-1745 FDA UDI
- Primary DI / UDI-DI
- 10381780536970 FDA UDI
- 510(k) Number
- K233448 FDA UDI
- FDA Product Code
- JXG FDA UDIHCA FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI882.4100 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 Safe FDA UDI
Dimensions & Sizes
- Size
- Catheter Length — 35 Centimeter FDA UDICatheter Inner Diameter — 1.5 Millimeter 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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Cleared under the same submission
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 30336984-1be1-49a4-abac-d327077c353d 38 fields · synced Jun 9, 2026