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G3600321

by Medtronic Sofamor Danek, Inc.

Ref G3600321

G3600321 is a device classified as Class IIa in the EU and Class I in the US made by Medtronic Sofamor Danek, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-00643169528048) and listed in FDA GUDID since 29 Dec 2017 (UDI-DI 00643169528048), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-00643169528048 Basic UDI-DI 00643169528048UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00643169528048 UDI-DI Date29 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00643169528048 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00643169528048 listed 29 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00643169528048
  2. Registered EUDAMED B-00643169528048

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Fluted surgical drill bit, single-use
Device name
Flexible Oc Drill
Model / reference
G3600321
Primary DI / UDI-DI
00643169528048
Basic UDI-DI
B-00643169528048
FDA product code
HTW
EMDN code
Z12139085 Various orthopaedic and traumatology instruments - consumables
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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: Fluted surgical drill bit, single-use

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)