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Instrument 6541-4-004

by Howmedica Osteonics Corp.

Ref 6541-4-004Model 08858251004923TR

Instrument 6541-4-004 is a device classified as Class IIa in the EU and Class II in the US made by Howmedica Osteonics Corp., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 08858251004923TR) and listed in FDA GUDID since 15 May 2020 (UDI-DI 07613327396676), 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 Number08858251004923TR Basic UDI-DI 07613327396676UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327396676 UDI-DI Date15 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004923TR registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327396676 listed 15 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327396676
  2. Registered EUDAMED 08858251004923TR

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  • Withdrawn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
Sterile EUDAMED
Instrument GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
TF-030 - Class IIa - Sterile Threaded Pins - Gamma
Model / Ref / Catalog
6541-4-004, 08858251004923TR
Primary DI / UDI-DI
07613327396676
Basic UDI-DI
08858251004923TR
Direct marketing DI
07613327396676
FDA product code
JWH, MBH
EMDN code
L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3560, 888.3565
EU registration type
Standard device
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 II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)