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OsteoMed 320-0402

by Osteomed Corp.

Part of a family of 196 devices: see the family page

Ref 320-0402Model INSTRUMENTS

OsteoMed 320-0402 is a device classified as Class I in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 0806378BUDIO58SB) and listed in FDA GUDID since 22 Sep 2017 (UDI-DI 00845694036337), 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 Number0806378BUDIO58SB Basic UDI-DI 00845694036337UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694036337 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0806378BUDIO58SB registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 00845694036337 listed 22 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694036337
  2. Registered EUDAMED 0806378BUDIO58SB

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  • Withdrawn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
Acumed EUDAMED
OsteoMed GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
320-0402, INSTRUMENTS
Primary DI / UDI-DI
00845694036337
Basic UDI-DI
0806378BUDIO58SB
FDA product code
HRS
EMDN code
L0915 Spreaders and retractors for orthopaedic surgery, reusable
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 6.299 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

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