Identity
- Trade Name
- CODMAN HAKIM RICKHAM SIPHONGUARD FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- CODMAN HAKIM Programmable Valve Micro II Valve with RICKHAM Reservoir and SIPHONGUARD Device with Unitized Distal Catheter 120cm Programmable in steps of 10mm H2O (98Pa): 30mm H2O to 200mm H2O (294Pa-1960Pa) Includes: 14cm Ventricular Catheter, Stylet, Priming Adapter and Information Manual FDA UDI
- Model / Reference
- NS5061 FDA UDI
- Description
- CODMAN HAKIM Programmable Valve Micro II Valve with RICKHAM Reservoir and SIPHONGUARD Device with Unitized Distal Catheter 120cm Programmable in steps of 10mm H2O (98Pa): 30mm H2O to 200mm H2O (294Pa-1960Pa) Includes: 14cm Ventricular Catheter, Stylet, Priming Adapter and Information Manual FDA UDI
Identifiers
- Catalog Number
- NS5061 FDA UDI
- Primary DI / UDI-DI
- 10886704046844 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
MR Conditional FDA UDI
Codman Hakim Rickham Siphonguard 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 19ae6440-583f-40c3-8daf-ca572e1bb6c2 37 fields · synced Jun 1, 2026