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Swanson 64800100

by Wright Medical Technology, Inc.

Ref 64800100Model 08858251007131T5

Swanson 64800100 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 08858251007131T5) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00840420190208), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251007131T5 Basic UDI-DI 00840420190208UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420190208 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251007131T5 registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00840420190208 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420190208
  2. Registered EUDAMED 08858251007131T5

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  • Withdrawn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
Swanson
Generic name
Orthopaedic broach
Device name
SWANSON Fingers Instrumentation- Broaching Instrumentation- Class l- Reusable- Nonsterile
Model / Ref / Catalog
64800100, 08858251007131T5
Primary DI / UDI-DI
00840420190208
Basic UDI-DI
08858251007131T5
Direct marketing DI
00840420190208
FDA product code
HTQ
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic broach
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic broach

Similar devices in this category

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

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

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