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Arthrex® ABS-2000-OT

by Arthrex, Inc.

Ref ABS-2000-OTModel IOBP, Core Decompression and DeliveryKit

Arthrex ABS-2000-OT is a general-purpose syringe (EU MDD Class IIa; FDA Class II; FDA product code FMF, Syringe, piston) made by Arthrex, Inc., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI B-00888867284876) and listed in FDA GUDID since 25 Sep 2017 (UDI-DI 00888867284876), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00888867284876 Basic UDI-DI 00888867284876UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867284876 UDI-DI Date25 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00888867284876 registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 00888867284876 listed 25 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867284876
  2. Registered EUDAMED B-00888867284876

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  • Withdrawn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
Arthrex®
Generic name
General-purpose syringe, single-use
Model / Ref / Catalog
ABS-2000-OT, IOBP, Core Decompression and DeliveryKit
Primary DI / UDI-DI
00888867284876
Basic UDI-DI
B-00888867284876
FDA product code
FMF
EMDN code
A99 Devices for administration, withdrawal and collection - other
GMDN term
General-purpose syringe, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5860
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: General-purpose syringe, single-use

Similar devices in this category

Other devices filed under DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

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