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Ibs™

by In2Bones SAS 25 variants

Ref G01 01362

Ibs™ (G01 01362) is a device classified as Class IIa in the EU and Class I in the US made by In2Bones SAS, registered in EUDAMED on 24 Apr 2026 (Basic UDI-DI B-03760225714492) and listed in FDA GUDID since 9 Jun 2020 (UDI-DI 03760225714492), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760225714492 Basic UDI-DI 03760225714492UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225714492 UDI-DI Date9 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03760225714492 registered 24 Apr 2026 Active
  • FDA GUDID UDI-DI 03760225714492 listed 9 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760225714492
  2. Registered EUDAMED B-03760225714492

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  • Withdrawn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, reusable
Device name
I.B.S®-C Compression and I.B.S®-N Neutralization osteosynthesis Instruments
Model / Ref / Catalog
G01 01362
Primary DI / UDI-DI
03760225714492
Basic UDI-DI
B-03760225714492
FDA product code
GFG
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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
FR-MF-000005246

Related devices

Category: Wire holding/twisting forceps

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from In2Bones SAS

See all devices from In2Bones SAS →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Manufacturing date
Other properties (21, all answered No)