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Arthrex® AR-1345SE-15

by Arthrex, Inc.

Ref AR-1345SE-15

Arthrex® AR-1345SE-15 is a Class I device made by Arthrex, Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0888867BonePrepNS000000MF) and listed in FDA GUDID since 27 Jul 2022 (UDI-DI 00888867402713), 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 Number0888867BonePrepNS000000MF Basic UDI-DI 00888867402713UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867402713 UDI-DI Date27 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888867BonePrepNS000000MF registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00888867402713 listed 27 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867402713
  2. Registered EUDAMED 0888867BonePrepNS000000MF

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  • Withdrawn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
Arthrex EUDAMED
Arthrex® GUDID
Generic name
Bone lever/elevator, reusable
Device name
Bone-Tissue Prep Non-sterile
Model / Ref / Catalog
AR-1345SE-15
Primary DI / UDI-DI
00888867402713
Basic UDI-DI
0888867BonePrepNS000000MF
FDA product code
LXH
EMDN code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN term
Bone lever/elevator, 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 lever/elevator, reusable

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)