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Instrument 6541-4-006

by Howmedica Osteonics Corp.

Ref 6541-4-006Model 08858251004923TR

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251004923TR Basic UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327460292 UDI-DIDate21 Sep 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
6541-4-006, 08858251004923TR
Primary DI / UDI-DI
07613327460292
Basic UDI-DI
08858251004923TR
FDA Product Code
MBH, JWH
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
888.3565, 888.3560
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

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No