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gSource gS 82.7715

by Gsource, LLC.

Part of a family of 7 devices: see the family page

Ref gS 82.7715

gSource gS 82.7715 is a Class I device made by Gsource, LLC., registered in EUDAMED on 19 May 2026 (Basic UDI-DI 08403142HOLDINGDA) and listed in FDA GUDID since 20 Mar 2026 (UDI-DI 00840314270221), 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 Number08403142HOLDINGDA Basic UDI-DI 00840314270221UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840314270221 UDI-DI Date20 Mar 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08403142HOLDINGDA registered 19 May 2026 Active
  • FDA GUDID UDI-DI 00840314270221 listed 20 Mar 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840314270221
  2. Registered EUDAMED 08403142HOLDINGDA

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  • Withdrawn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
gRod Bender, In Situ, 13", Angled, Ø5.5mm, Right EUDAMED
gSource GUDID
Generic name
Manual orthopaedic bender, reusable
Model / Ref / Catalog
gS 82.7715
Primary DI / UDI-DI
00840314270221
Basic UDI-DI
08403142HOLDINGDA
Direct marketing DI
00840314270221
FDA product code
LXH
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Manual orthopaedic bender, reusable
Device class
Class I
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

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)