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Codman® Hakim® 823813

by Integra LifeSciences Production Corporation

Ref 82-3813

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780534907 Basic UDI-DI 10381780534907UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780534907 UDI-DI Date13 Jul 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Codman® Hakim®
Generic Name
Cerebrospinal fluid shunt valve
Device Name
Precision Valve
Model / Ref / Catalog
82-3813, 823813
Primary DI / UDI-DI
10381780534907
Basic UDI-DI
B-10381780534907
510(k) Number
FDA Product Code
JXG
EMDN Code
N010301 Ventricular-peritoneal shunts
GMDN Term
Cerebrospinal fluid shunt valve
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
882.5550
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
82-3813
GUDID
823813
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Cerebrospinal fluid shunt valve

Cleared under the same submission (K221840)

Show all (12)

Other devices from Integra LifeSciences Production Corporation

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No