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OsteoMed 206-0300

by Osteomed Corp.

Ref 206-0300Model INSTRUMENTS

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0806378BUDIO58SB Basic UDI-DI 00845694015813UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694015813 UDI-DI Date1 Apr 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Craniofacial bone screw, non-bioabsorbable
Model / Ref / Catalog
206-0300, INSTRUMENTS
Primary DI / UDI-DI
00845694015813
Basic UDI-DI
0806378BUDIO58SB
FDA Product Code
JEY
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN Term
Craniofacial bone screw, non-bioabsorbable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.4760
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 2.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Craniofacial bone screw, non-bioabsorbable

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No