Identity
- Trade Name
- CODMAN HAKIM FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- CODMAN HAKIM Precision Fixed Pressure Valve Micro ll Valve with Unitized Ventricular and Unitized Distal Catheter Operating Pressure: 130mm H2O Plus or Minus 10mm H2O (1274 Pa Plus or Minus 98 Pa) High Range Includes: Precision Valve, 8.5cm Unitized Ventricular Catheter, 120cm Unitized Peritoneal Catheter, Stylet, Right Angle Adapter, Priming Adapter and Information Manual FDA UDI
- Model / Reference
- NS5120 FDA UDI
- Description
- CODMAN HAKIM Precision Fixed Pressure Valve Micro ll Valve with Unitized Ventricular and Unitized Distal Catheter Operating Pressure: 130mm H2O Plus or Minus 10mm H2O (1274 Pa Plus or Minus 98 Pa) High Range Includes: Precision Valve, 8.5cm Unitized Ventricular Catheter, 120cm Unitized Peritoneal Catheter, Stylet, Right Angle Adapter, Priming Adapter and Information Manual FDA UDI
Identifiers
- Catalog Number
- NS5120 FDA UDI
- Primary DI / UDI-DI
- 10886704047315 FDA UDI
- 510(k) Number
- K091346 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
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
No
FDA UDI
Codman Hakim by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 c0bc7d7d-0644-46cc-9cac-d9392c0263b6 37 fields · synced Jun 8, 2026