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GFS Naked 10789

by Parcus Medical LLC

Ref 10789Model GFS Naked

GFS Naked 10789 is a device classified as Class IIb in the EU and Class II in the US made by Parcus Medical LLC, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-00816342021937) and listed in FDA GUDID since 26 Jul 2023 (UDI-DI 00816342021937), active as of 22 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-00816342021937 Basic UDI-DI 00816342021937UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816342021937 UDI-DI Date26 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816342021937 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00816342021937 listed 26 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816342021937
  2. Registered EUDAMED B-00816342021937

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Gfs Mini Naked EUDAMED
GFS Naked GUDID
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / reference
10789, GFS Naked
Primary DI / UDI-DI
00816342021937
Basic UDI-DI
B-00816342021937
FDA product code
MBI
EMDN code
H900301 Suture buttons
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under SUTURE DEVICES - VARIOUS.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)