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Tornier Perform MWE151

by Tornier, Inc.

Ref MWE151Model 08858251028054U9

Tornier Perform MWE151 is a surgical screwdriver (EU MDR Class IIa; FDA Class I; FDA product code GFG, Bit, Surgical) made by Tornier, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 08858251028054U9) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386973871), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251028054U9 Basic UDI-DI 03700386973871UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386973871 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028054U9 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 03700386973871 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386973871
  2. Registered EUDAMED 08858251028054U9

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  • Withdrawn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

Trade name
Tornier Perform® Anatomic Glenoid EUDAMED
Tornier Perform GUDID
Generic name
Surgical screwdriver, reusable
Device name
Tornier Perform Anatomic Glenoid Instrumentation - Handles and Adaptors - Class Iia - Non Sterile
Model / Ref / Catalog
MWE151, 08858251028054U9
Description
CANNULATED REAMER DRIVER
Primary DI / UDI-DI
03700386973871
Basic UDI-DI
08858251028054U9
Direct marketing DI
03700386973871
FDA product code
GFG
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

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