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OsteoMed 218-1605

by Osteomed Corp.

OsteoMed 218-1605 is a Class II device made by Osteomed Corp., listed in FDA GUDID since 7 Apr 2015 (UDI-DI 00845694034265), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00845694034265 UDI-DI Date7 Apr 2015ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
OsteoMed
Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog
218-1605
Primary DI / UDI-DI
00845694034265
FDA product code
GWO
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class II
Regulation number
882.5320
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 5 Millimeter

Similar devices in this category

Other devices filed under Craniofacial fixation plate, non-bioabsorbable, non-customized.

Other devices from Osteomed Corp.

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)