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2351-0011

by Stryker GmbH

Ref 2351-0011Model 08858251002596TJ

2351-0011 is a bone awl (EU MDR Class I; FDA Class I; FDA product code HWJ, Awl) made by Stryker GmbH, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 08858251002596TJ) and listed in FDA GUDID since 2 Nov 2018 (UDI-DI 07613327361834), active as of 12 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002596TJ Basic UDI-DI 07613327361834UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327361834 UDI-DI Date2 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002596TJ registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327361834 listed 2 Nov 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327361834
  2. Registered EUDAMED 08858251002596TJ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Bone awl, reusable
Device name
Imn Instruments - Handles and Adaptors - Class I - Reusable - Non Sterile
Model / Ref / Catalog
2351-0011, 08858251002596TJ
Primary DI / UDI-DI
07613327361834
Basic UDI-DI
08858251002596TJ
Direct marketing DI
07613327361834
FDA product code
HWJ
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone awl, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone awl, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)