Skip to content

Tap, Bone XT04700

by Parcus Medical LLC

Ref XT04700

Tap, Bone XT04700 is a Class I device made by Parcus Medical LLC, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 081634202TD00BWM) and listed in FDA GUDID since 13 Jul 2022 (UDI-DI 00816342025423), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081634202TD00BWM Basic UDI-DI 00816342025423UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816342025423 UDI-DI Date13 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081634202TD00BWM registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 00816342025423 listed 13 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816342025423
  2. Registered EUDAMED 081634202TD00BWM

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  • Withdrawn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
X-Twist 4.75 Tap EUDAMED
Tap, Bone GUDID
Generic name
Bone tap, reusable
Device name
Reusable Surgical Instruments
Model / reference
XT04700
Primary DI / UDI-DI
00816342025423
Basic UDI-DI
081634202TD00BWM
Direct marketing DI
00816342025423
FDA product code
HWX
EMDN code
L0927 Orthopaedic surgery manual perforators, reusable
GMDN term
Bone tap, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Parcus Medical LLC

See all devices from Parcus Medical LLC →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)