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DSDS0065

by Wright Medical Technology, Inc.

Ref DSDS0065Model 08858251028149UM

DSDS0065 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 08858251028149UM) and listed in FDA GUDID since 18 Dec 2023 (UDI-DI 00889797046688), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251028149UM Basic UDI-DI 00889797046688UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797046688 UDI-DI Date18 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028149UM registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 00889797046688 listed 18 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797046688
  2. Registered EUDAMED 08858251028149UM

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  • Withdrawn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
Dart-Fire®
Generic name
Instrument tray, reusable
Device name
Dartfire Screws Instrumentation - Trays and Tray Accessories - Class I - Nonsterile
Model / Ref / Catalog
DSDS0065, 08858251028149UM
Primary DI / UDI-DI
00889797046688
Basic UDI-DI
08858251028149UM
Direct marketing DI
00889797046688
FDA product code
LRP
EMDN code
L098099 Orthopaedic and traumatological surgery instruments, reusable - other accessories
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
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: Instrument tray, reusable

Similar devices in this category

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

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

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