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Ibs-B

by In2Bones, USA 23 variants

Ref G01 N0085, G01 N0093, G01 N0084

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08101755028147 Basic UDI-DI Date27 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810021867939 UDI-DI Date12 Dec 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Surgical drill guide, reusable
Surgical screwdriver, reusable
Device Name
Non-patient-contacting Class I instruments, Non-Active
Model / Ref / Catalog
G01 N0085, G01 N0093, G01 N0084
Primary DI / UDI-DI
00810021867939, 00810021869742, 00810021869759
Basic UDI-DI
08101755028147
FDA Product Code
LXH
EMDN Code
L091104, L091102
GMDN Term
Surgical drill guide, reusable
Surgical screwdriver, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Manufacturer details

EUDAMED SRN
US-MF-000023092
Authorised representative
Conmed Europe BV BE-AR-000035662

Related devices

Category: Orthopaedic implant impactor, reusable

Other devices from In2Bones, USA

See all devices from In2Bones, USA →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No