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Instrument 6541-4-700

by Howmedica Osteonics Corp.

Ref 6541-4-700Model 08858250000808SB

Instrument 6541-4-700 is a Class I device made by Howmedica Osteonics Corp., registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 08858250000808SB) and listed in FDA GUDID since 13 Nov 2017 (UDI-DI 07613327240450), 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 Number08858250000808SB Basic UDI-DI 07613327240450UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327240450 UDI-DI Date13 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000808SB registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327240450 listed 13 Nov 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327240450
  2. Registered EUDAMED 08858250000808SB

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  • Withdrawn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
Instrument
Generic name
Bone file/rasp, manual, reusable
Device name
TF-018 Class I (r) - Scraping
Model / Ref / Catalog
6541-4-700, 08858250000808SB
Primary DI / UDI-DI
07613327240450
Basic UDI-DI
08858250000808SB
Direct marketing DI
07613327240450
FDA product code
HTP
EMDN code
L091202 Orthopaedic surgery files, reusable
GMDN term
Bone file/rasp, manual, reusable
Device class
Class I
Regulation number
888.4540
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: Bone file/rasp, manual, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY FILES, REUSABLE.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)