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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
Precision Fixed Pressure Valve Right Angle Valve with SIPHONGUARD® Device Low Range FDA UDI
Model / Reference
825482 FDA UDI
Description
Precision Fixed Pressure Valve Right Angle Valve with SIPHONGUARD® Device Low Range FDA UDI

Identifiers

Catalog Number
82-5482 FDA UDI
Primary DI / UDI-DI
10381780535270 FDA UDI
510(k) Number
K221840 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
MRI Safety
MR Conditional 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

K221840 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 9bf9b958-6682-4069-bebe-0c0a8047af7e 37 fields · synced Jun 9, 2026