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2570705P

by Wright Medical Technology, Inc.

Part of a family of 16 devices: see the family page

Ref 2570705PModel 08897970056AMX

2570705P is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 08897970056AMX) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00840420188816), 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 Number08897970056AMX Basic UDI-DI 00840420188816UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420188816 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08897970056AMX registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 00840420188816 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420188816
  2. Registered EUDAMED 08897970056AMX

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  • Withdrawn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
Bone file/rasp, manual, reusable
Device name
SWANSON Flexible Finger Joint Instruments - BONE SURFACE PREPARATION INSTRUMENTATION - CLASS l - Reusable - Nonsterile
Model / Ref / Catalog
2570705P, 08897970056AMX
Primary DI / UDI-DI
00840420188816
Basic UDI-DI
08897970056AMX
Direct marketing DI
00840420188816
FDA product code
GAC
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
Bone file/rasp, manual, reusable
Device class
Class I
Regulation number
878.4800
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: Bone file/rasp, manual, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, REUSABLE.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)