Identity
- Trade Name
- CODMAN HAKIM BACTISEAL FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL Catheters Operating Pressure: 10mm H2O Very Low Range Includes: BACTISEAL Ventricular Catheter 14cm, Stylet, Unitized BACTISEAL Peritoneal Catheter 120cm, Right Angle Adapter, Priming Adapter and Information Manual FDA UDI
- Model / Reference
- NS5471 FDA UDI
- Description
- CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL Catheters Operating Pressure: 10mm H2O Very Low Range Includes: BACTISEAL Ventricular Catheter 14cm, Stylet, Unitized BACTISEAL Peritoneal Catheter 120cm, Right Angle Adapter, Priming Adapter and Information Manual FDA UDI
Identifiers
- Catalog Number
- NS5471 FDA UDI
- Primary DI / UDI-DI
- 10886704048138 FDA UDI
- 510(k) Number
- K020667 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculoperitoneal shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Codman Hakim Bactiseal by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K020667 also covers:
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI ef0875ac-7c73-41ba-af0a-af731d8cfc13 38 fields · synced May 31, 2026