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Headless Screw System Instruments T001000100

by Tyber Medical

Part of a family of 168 devices: see the family page

Ref T001000100

Headless Screw System Instruments T001000100 is a device classified as Class IIa in the EU and Class I in the US made by Tyber Medical, registered in EUDAMED on 12 Mar 2026 (Basic UDI-DI 019644901457) and listed in FDA GUDID since 14 Jan 2020 (UDI-DI 00810030824640), active as of 22 Oct 2026.

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

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number019644901457 Basic UDI-DI 00810030824640UDI-DIDate12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810030824640 UDI-DI Date14 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 019644901457 registered 12 Mar 2026 Active
  • FDA GUDID UDI-DI 00810030824640 listed 14 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810030824640
  2. Registered EUDAMED 019644901457

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  • Withdrawn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
Headless Screw System Instruments
Generic name
Surgical countersink, single-use
Device name
Instruments
Model / Ref / Catalog
T001000100
Primary DI / UDI-DI
00810030824640
Basic UDI-DI
019644901457
FDA product code
LXH
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Surgical countersink, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
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
Contains latexEUDAMED
Yes
GUDID
No

Registry differences

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

  • Contains latex UDI-DI 00810030824640: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Category: Surgical countersink, single-use

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER.

Other devices from Tyber Medical

See all devices from Tyber Medical →

Properties

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