Skip to content

Omni Stable AF

by Extremity Medical, LLC 7 variants

Ref 155-03510

Omni Stable AF (155-03510) is a device classified as Class IIa in the EU and Class I in the US made by Extremity Medical, LLC, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00842078123331) and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 00842078123331), active as of 9 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00842078123331 Basic UDI-DI 00842078123331UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842078123331 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00842078123331 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00842078123331 listed 29 Oct 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00842078123331
  2. Registered EUDAMED B-00842078123331

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  • Withdrawn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

Generic name
Fluted surgical drill bit, single-use
Model / reference
155-03510
Primary DI / UDI-DI
00842078123331
Basic UDI-DI
B-00842078123331
FDA product code
HTW
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00842078123331: EUDAMED states No, FDA GUDID states Yes.

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.

Manufacturer details

EUDAMED SRN
US-MF-000018334
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (18, all answered No)