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Codman® Hakim®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
CODMAN® HAKIM® FDA UDI
Generic Name
Cerebrospinal fluid shunt valve FDA UDI
Device Name
CODMAN® HAKIM® Precision Fixed Pressure Valve Micro Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Range FDA UDI
Model / Reference
823029 FDA UDI
Description
CODMAN® HAKIM® Precision Fixed Pressure Valve Micro Valve, Operating Pressure: 100mm H2O ± 10mm H2O (980 Pa ± 98 Pa) Medium High Range FDA UDI

Identifiers

Catalog Number
82-3029 FDA UDI
Primary DI / UDI-DI
10381780518747 FDA UDI
510(k) Number
K973774 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
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

Yes

FDA UDI

Category: Cerebrospinal fluid shunt valve

Codman® Hakim® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cerebrospinal fluid shunt valve.

Cleared under the same submission

K973774 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 285b295c-4e37-4ee7-a538-a17bf787d5e7 37 fields · synced Jun 9, 2026