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Darco DC4197

by Wright Medical Technology, Inc.

Ref DC4197Model 08858251006838UF

Darco DC4197 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 08858251006838UF) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00840420191892), 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 Number08858251006838UF Basic UDI-DI 00840420191892UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420191892 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006838UF registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 00840420191892 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420191892
  2. Registered EUDAMED 08858251006838UF

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  • Withdrawn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
Darco™ EUDAMED
Darco GUDID
Generic name
Surgical implant handling forceps
Device name
Darco Plantar Lapidus Instrumentation - Forceps - Class I - Reusable - Nonsterile
Model / Ref / Catalog
DC4197, 08858251006838UF
Primary DI / UDI-DI
00840420191892
Basic UDI-DI
08858251006838UF
Direct marketing DI
00840420191892
FDA product code
HTD
EMDN code
L091103 Orthopaedic prostheses forceps, reusable
GMDN term
Surgical implant handling forceps
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: Surgical implant handling forceps

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES FORCEPS, REUSABLE.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, 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)