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Codman® Hakim®

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 82-1733Ref 82-3055

by Integra LifeSciences Production Corporation

Identity

Trade Name
CODMAN® EUDAMEDFDA UDI
CODMAN® HAKIM® FDA UDI
Generic Name
Ventriculoperitoneal shunt FDA UDI
Subcutaneous tunneller, single-use FDA UDI
Device Name
Leveling Device EUDAMED
Valve Introducer EUDAMED
CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device and Unitized Distal Catheter FDA UDI
CODMAN® Valve Introducer FDA UDI
Model / Reference
82-1733 EUDAMED
82-3055 EUDAMED
823821 FDA UDI
823055 FDA UDI
Description
CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device and Unitized Distal Catheter FDA UDI
CODMAN® Valve Introducer FDA UDI

Identifiers

Catalog Number
82-3821 FDA UDI
82-3055 FDA UDI
Primary DI / UDI-DI
10381780518884 EUDAMEDFDA UDI
10381780518365 EUDAMED
10381780519751 FDA UDI
Basic UDI-DI
038178B0070CSS3F EUDAMED
B-10381780518884 EUDAMED
510(k) Number
K992173 FDA UDI
FDA Product Code
JXG FDA UDI
EMDN Code
A060199 SURGICAL DRAINAGE SYSTEMS - OTHER EUDAMED
N01038099 INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER EUDAMED
GMDN Term
Ventriculoperitoneal shunt FDA UDI
Subcutaneous tunneller, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMED

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDIFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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: Ventriculoperitoneal shunt

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

Similar devices

Also classified as Ventriculoperitoneal shunt.

Cleared under the same submission

K992173 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (4)

  • FDA UDI 68485a7a-d2d7-482b-a90d-ab29b771461f 37 fields · synced Sep 17, 2026
  • FDA UDI a1a056e4-e07c-4815-9511-48b15dea0527 36 fields · synced May 29, 2026
  • EUDAMED 637c9e2c-f831-40ba-ba2b-ec1075315fa9 61 fields · synced Jul 8, 2026
  • EUDAMED 7840b449-90bf-4614-9837-c93cfb9600e8 61 fields · synced Sep 17, 2026