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Instruments

by Tyber Medical 134 variants

Ref 03.333.013.04

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number019644901457 Basic UDI-DI 00810040684159UDI-DIDate12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810040684159 UDI-DI Date20 Aug 2020ListedStatusListed 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  • Withdrawn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

Trade Name
Cannulated Screw System +
Generic Name
Orthopaedic bone pin, non-bioabsorbable
Device Name
Instruments
Model / Ref / Catalog
03.333.013.04
Primary DI / UDI-DI
00810040684159
Basic UDI-DI
019644901457
FDA Product Code
LXH
EMDN Code
L0922 Orthopaedic surgery guides, reusable
GMDN Term
Orthopaedic bone pin, non-bioabsorbable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-MF-000011350
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Tyber Medical

See all devices from Tyber Medical →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (18)

  • Sterile: 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
  • Manufacturing Date: No