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Accessories, arthroscopic 10162

by Parcus Medical LLC

Part of a family of 21 devices: see the family page

Ref 10162

Accessories, arthroscopic 10162 is a tendon/ligament graft preparation station (EU MDR Class I; FDA Class I; FDA product code NBH, Accessories, arthroscopic) made by Parcus Medical LLC, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 081634202TD00DWR) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 00816342024570), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081634202TD00DWR Basic UDI-DI 00816342024570UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816342024570 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081634202TD00DWR registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 00816342024570 listed 7 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816342024570
  2. Registered EUDAMED 081634202TD00DWR

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  • Withdrawn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
Fixed Post Clamp Assembly EUDAMED
Accessories, arthroscopic GUDID
Generic name
Tendon/ligament graft preparation station
Device name
Non-invasive Surgical Instruments
Model / reference
10162
Primary DI / UDI-DI
00816342024570
Basic UDI-DI
081634202TD00DWR
Direct marketing DI
00816342024570
FDA product code
NBH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Tendon/ligament graft preparation station
Device class
Class I
Regulation number
888.1100
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Parcus Medical LLC

See all devices from Parcus Medical LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)