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Tornier Perform MWJ127

by Tornier, Inc.

Ref MWJ127Model 08858251006356TQ

Tornier Perform MWJ127 is an orthopaedic implant driver (EU MDR Class I; FDA Class I; FDA product code GFG, Bit, Surgical) made by Tornier, Inc., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 08858251006356TQ) and listed in FDA GUDID since 22 Sep 2022 (UDI-DI 00846832062492), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006356TQ Basic UDI-DI 00846832062492UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832062492 UDI-DI Date22 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006356TQ registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00846832062492 listed 22 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832062492
  2. Registered EUDAMED 08858251006356TQ

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  • Withdrawn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® Reversed Glenoid EUDAMED
Tornier Perform GUDID
Generic name
Orthopaedic implant driver
Device name
Tornier Perform Reversed Glenoid Instruments - Screwdrivers and Tightening Instrument - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWJ127, 08858251006356TQ
Primary DI / UDI-DI
00846832062492
Basic UDI-DI
08858251006356TQ
Direct marketing DI
00846832062492
FDA product code
GFG
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Orthopaedic implant driver
Device class
Class I
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

Related devices

Category: Orthopaedic implant driver

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)