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DWD168

by Tornier, Inc.

Ref DWD168Model 370038690097XZ7

DWD168 is a device classified as Class IIa in the EU and Class I in the US made by Tornier, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 370038690097XZ7) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386943966), 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 Number370038690097XZ7 Basic UDI-DI 03700386943966UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386943966 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 370038690097XZ7 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 03700386943966 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386943966
  2. Registered EUDAMED 370038690097XZ7

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  • Withdrawn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
Generic name
Orthopaedic bur, reusable
Device name
Tornier Perform Anatomic Glenoid Instrumentation - Guide-Wires, K-Wires, Pins - Class Iia - Sterile
Model / Ref / Catalog
DWD168, 370038690097XZ7
Primary DI / UDI-DI
03700386943966
Basic UDI-DI
370038690097XZ7
FDA product code
HWE
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic bur, 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
Size
Length — 200 Millimeter
Outer Diameter — 2.5 Millimeter

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: Orthopaedic bur, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)