Skip to content

OsteoMed 339-4064-SP

by Osteomed Corp.

Ref 339-4064-SP

OsteoMed 339-4064-SP is a device classified as Class IIb in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00842528114391) and listed in FDA GUDID since 26 Oct 2018 (UDI-DI 00842528114391), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00842528114391 Basic UDI-DI 00842528114391UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842528114391 UDI-DI Date26 Oct 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00842528114391 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 00842528114391 listed 26 Oct 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00842528114391
  2. Registered EUDAMED B-00842528114391

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  • Withdrawn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
Acumed EUDAMED
OsteoMed GUDID
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
Trial
Model / Ref / Catalog
339-4064-SP
Primary DI / UDI-DI
00842528114391
Basic UDI-DI
B-00842528114391
FDA product code
HRS
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Size
Length — 64 Millimeter

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes
Sterilise before useEUDAMED
Yes
GUDID
No
ImplantableEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00842528114391: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 00842528114391: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)