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Codman Hakim

FDA UDI

Class II (US FDA UDI)

by Cerenovus, Inc.

Identity

Trade Name
CODMAN HAKIM FDA UDI
Generic Name
Cerebrospinal fluid shunt valve FDA UDI
Device Name
CODMAN HAKIM Precision Fixed Pressure Valve MICRO II Valve with Unitized Single Dome Reservoir Operating Pressure: 130mm H2O Plus or Minus 10mm H2O (1274 Pa Plus or Minus 98 Pa) High Range Includes: Straight Connector, Priming Adapter and Information Manual FDA UDI
Model / Reference
NS0635 FDA UDI
Description
CODMAN HAKIM Precision Fixed Pressure Valve MICRO II Valve with Unitized Single Dome Reservoir Operating Pressure: 130mm H2O Plus or Minus 10mm H2O (1274 Pa Plus or Minus 98 Pa) High Range Includes: Straight Connector, Priming Adapter and Information Manual FDA UDI

Identifiers

Catalog Number
NS0635 FDA UDI
Primary DI / UDI-DI
10886704046349 FDA UDI
510(k) Number
K091346 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Cerebrospinal fluid shunt valve 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

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Manufacturer

Manufacturer
Cerenovus, Inc.

Sources (1)

  • FDA UDI c40c603e-08be-4dda-bc0d-1d61fec77c02 37 fields · synced May 31, 2026