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Arthrex® AR-13920DS

by Arthrex, Inc.

Ref AR-13920DS

Arthrex® AR-13920DS is a device classified as Class IIb in the EU and Class II in the US made by Arthrex, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-00888867015661) and listed in FDA GUDID since 15 Feb 2017 (UDI-DI 00888867015661), 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-00888867015661 Basic UDI-DI 00888867015661UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867015661 UDI-DI Date15 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00888867015661 registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 00888867015661 listed 15 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867015661
  2. Registered EUDAMED B-00888867015661

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  • Withdrawn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
Arthroscopic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
AR-13920DS
Primary DI / UDI-DI
00888867015661
Basic UDI-DI
B-00888867015661
FDA product code
GAT
EMDN code
H0102010299 Synthetic nonabsorbable multifilament sutures - other
GMDN term
Arthroscopic surgical procedure kit, non-medicated, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.5000
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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: Arthroscopic surgical procedure kit, non-medicated, single-use

Similar devices in this category

Other devices filed under SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)