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254641

by DePuy Mitek, Inc.

Ref 254641

254641 is a Class I device made by DePuy Mitek, Inc., registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI B-USMF000045334000072TX) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI D-USMF000045334000072TX), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000045334000072TX Basic UDI-DI D-USMF000045334000072TXUDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF000045334000072TX UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-USMF000045334000072TX registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI D-USMF000045334000072TX listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-USMF000045334000072TX
  2. Registered EUDAMED B-USMF000045334000072TX

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  • Withdrawn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

Generic name
Surgical screwdriver, reusable
Model / Ref / Catalog
254641
Primary DI / UDI-DI
D-USMF000045334000072TX EUDAMED
10886705013333 GUDID
Basic UDI-DI
B-USMF000045334000072TX
FDA product code
LXH
EMDN code
L0399 General surgery instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000045334000072TX
GUDID
10886705013333

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000045334000072TX; FDA GUDID lists 10886705013333), so their flags are not compared.

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under GENERAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from DePuy Mitek, Inc.

See all devices from DePuy Mitek, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)