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Instruments

by Tyber Medical 134 variants

Ref 03.426.690, 03.527.205S, 03.426.570, 03.426.732, 03.426.630, 03.426.121S, 03.426.732S, 03.426.730, 770003200A, T001000044, 03.333.002

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

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 Date12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00196449023486 UDI-DI Date15 Dec 2023ListedStatusListed GUDID: 39 of 40 UDI-DIs 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  • Withdrawn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
A.L.P.S. mvX™
Headed Screw System Instruments
Cannulated Screw Guide Pin
Cannulated Headless Screw - Full Thread
Headless Screw System Instruments
Cannulated Screw System +
Cannulated Compression Headless Screw
Omnia Medical TLS Instruments
Generic Name
Cannulated surgical drill bit, single-use
Surgical countersink, single-use
Orthopaedic guidewire, single-use
Surgical countersink, reusable
Orthopaedic intraoperative positioning pin, single-use
Orthopaedic bone pin, non-bioabsorbable
Orthopaedic bone screw (non-sliding)
Cannulated surgical drill bit, reusable
Device Name
Instruments
Model / Ref / Catalog
03.426.690, 03.527.205S, 03.426.570, 03.426.732, 03.426.630, 03.426.121S, 03.426.732S, 03.426.730, T001000044, 03.333.002, 770003200A, 770002201, T009000040, 770002250, 770002200, 28ZBGP450, 770003200, 770003400, 03.333.917, T001000005, 770002181, 770015240, 03.333.015S, 770018090, T001000002, 03.333.104, 770015130, 770002100, 03.333.917S, 03.333.200, 770008240, OM-TLS5-30D, 03.333.102S, 770900004, 770002180, T001145209, 03.333.912, T009000038, T001120116, T001000047, T001000003, 03.333.923S, 770900006, 770002182, T001000007, T001155289, 03.333.913S, 03.333.201, 770018160
Primary DI / UDI-DI
00196449023486, 00196449023349, 00196449023448, 00196449023530, 00196449023455, 00196449023677, 00196449023547, 00196449023493, 00810030824626, 00819917026450, 00196449017508, 00196449015344, 00810030824602, 00196449015351, 00196449015337, 00810030825043, 00196449016495, 00196449015382, 00196449024544, 00810030824565, 00196449012916, 00196449010127, 00810040681967, 00196449010158, 00810030824534, 00819917026597, 00196449010110, 00196449016457, 00196449024551, 00819917026658, 00196449010103, M695OMTLS530D0, 00819917026627, 00196449011704, 00196449016488, 00810030824725, 00196449024445, 00810030824596, 00810030824695, 00810030824633, 00810030824541, 00196449024674, 00196449011728, 00196449012923, 00810030824589, 00810030824732, 00196449024476, 00819917026665, 00196449010141
Basic UDI-DI
019644901457
FDA Product Code
HTW, LXH, HWW
EMDN Code
Z12139099, Z12130503, L0922
GMDN Term
Cannulated surgical drill bit, single-use
Surgical countersink, single-use
Orthopaedic guidewire, single-use
Surgical countersink, reusable
Orthopaedic intraoperative positioning pin, single-use
Orthopaedic bone pin, non-bioabsorbable
Orthopaedic bone screw (non-sliding)
Cannulated surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Belgium
Germany
GUDID distribution status
In Commercial Distribution (UDI-DI 00196449015344, 00810030824602, 00196449015351, 00196449015337, 00810030825043, 00196449016495, 00196449015382, 00196449024544, 00810030824565, 00196449012916, 00196449010127, 00810040681967, 00196449010158, 00810030824534, 00810030824626, 00819917026597, 00196449010110, 00196449016457, 00196449024551, 00819917026658, 00196449010103, 00819917026627, 00196449011704, 00196449016488, 00810030824725, 00196449024445, 00810030824596, 00810030824695, 00810030824633, 00819917026450, 00810030824541, 00196449024674, 00196449011728, 00196449012923, 00810030824589, 00810030824732, 00196449024476, 00819917026665, 00196449010141)
Not in Commercial Distribution (UDI-DI M695OMTLS530D0)
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

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

Manufacturer details

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

Related devices

Category: Orthopaedic guidewire, reusable

Other devices from Tyber Medical

See all devices from Tyber Medical →

Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Single Use YesGUDIDNoGUDID
  • Implantable NoEUDAMEDGUDIDYesGUDID
  • Reusable
  • Contains Latex NoEUDAMEDGUDIDYesEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (14)

  • 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