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Rasp 8095

by Zimmer, Inc.

Ref 8095

Rasp 8095 is a device classified as Class I in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 889024C7H9) and listed in FDA GUDID since 30 Jan 2020 (UDI-DI 00889024303652), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024C7H9 Basic UDI-DI 00889024303652UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024303652 UDI-DI Date30 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024C7H9 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024303652 listed 30 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024303652
  2. Registered EUDAMED 889024C7H9

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  • Withdrawn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
Rasp
Generic name
Joint prosthesis implantation kit, reusable
Device name
Extractor for Extractor Hook
Model / Ref / Catalog
8095
Primary DI / UDI-DI
00889024303652
Basic UDI-DI
889024C7H9
Direct marketing DI
00889024303652
FDA product code
LZO
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3353
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Joint prosthesis implantation kit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)