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Double Drill Guide 8241-97-000

by Biomet Orthopedics, Inc.

Ref 824197000

Double Drill Guide 8241-97-000 (824197000) is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-00887868447235) and listed in FDA GUDID since 17 Jul 2020 (UDI-DI 00887868447235), 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-00887868447235 Basic UDI-DI 00887868447235UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868447235 UDI-DI Date17 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00887868447235 registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868447235 listed 17 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868447235
  2. Registered EUDAMED B-00887868447235

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  • Withdrawn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

Trade name
Double Drill Guide
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
824197000, 8241-97-000
Primary DI / UDI-DI
00887868447235
Basic UDI-DI
B-00887868447235
FDA product code
FZX
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
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
Model / referenceEUDAMED
824197000
GUDID
8241-97-000

Related devices

Category: Surgical drill guide, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)