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Ball Nose Guide Wire 2810-01-100

by Biomet Orthopedics, Inc.

Ref 281001100

Ball Nose Guide Wire 2810-01-100 (281001100) is a device classified as Class IIa in the EU and Class I in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 889024-ZB002692-GZ) and listed in FDA GUDID since 23 May 2020 (UDI-DI 00887868570698), 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 Number889024-ZB002692-GZ Basic UDI-DI 00887868570698UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868570698 UDI-DI Date23 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002692-GZ registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868570698 listed 23 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868570698
  2. Registered EUDAMED 889024-ZB002692-GZ

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  • Withdrawn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
Ball Nose Guide Wire
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
281001100, 2810-01-100
Primary DI / UDI-DI
00887868570698 EUDAMED
00887868027864 GUDID
Basic UDI-DI
889024-ZB002692-GZ
FDA product code
FZX
EMDN code
P09120399 Bone fixation wires - other
GMDN term
Orthopaedic bone wire
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
281001100
GUDID
2810-01-100
Primary DI / UDI-DIEUDAMED
00887868570698
GUDID
00887868027864
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00887868570698; FDA GUDID lists 00887868027864), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone wire

Similar devices in this category

Other devices filed under BONE FIXATION WIRES - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)