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DSDS1011

by Wright Medical Technology, Inc.

Ref DSDS1011Model 08858251006601TE

DSDS1011 is a device classified as Class IIa in the EU and Class I in the US made by Wright Medical Technology, Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 08858251006601TE) and listed in FDA GUDID since 14 Oct 2022 (UDI-DI 00889797109727), 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 Number08858251006601TE Basic UDI-DI 00889797109727UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797109727 UDI-DI Date14 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006601TE registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797109727 listed 14 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797109727
  2. Registered EUDAMED 08858251006601TE

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  • Withdrawn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

Generic name
Orthopaedic bone wire
Device name
DARTFIRE Small Screws INSTRUMENTS - GUIDE-WIRES, K-WIRES, PINS - CLASS IIA - Non Sterile
Model / Ref / Catalog
DSDS1011, 08858251006601TE
Primary DI / UDI-DI
00889797109727
Basic UDI-DI
08858251006601TE
FDA product code
HWE
EMDN code
P09120301 Kirschner bone wires
GMDN term
Orthopaedic bone wire
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
Size
Length — 150 Millimeter
Outer Diameter — 1.1 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 bone wire

Similar devices in this category

Other devices filed under BONE FIXATION WIRES.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

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