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2351-0060

by Stryker Corp.

Ref 2351-0060Model 08858251002889U4

2351-0060 is a Class I device made by Stryker Corp., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 08858251002889U4) and listed in FDA GUDID since 2 Nov 2018 (UDI-DI 07613327361681), active as of 2 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002889U4 Basic UDI-DI 07613327361681UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327361681 UDI-DI Date2 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002889U4 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327361681 listed 2 Nov 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327361681
  2. Registered EUDAMED 08858251002889U4

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  • Withdrawn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
Surgical mallet
Device name
Imn Instruments - Impact Instrumentation - Class I - Non Sterile
Model / Ref / Catalog
2351-0060, 08858251002889U4
Primary DI / UDI-DI
07613327361681
Basic UDI-DI
08858251002889U4
Direct marketing DI
07613327361681
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Surgical mallet
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: Surgical mallet

Similar devices in this category

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

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)