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Orthomed Om 48-0372

by Ortho-Med, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB8034803720 UDI-DI Date16 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Orthomed
Generic Name
Bone fixation plate pliers
Model / Reference
OM 48-0372
Primary DI / UDI-DI
B8034803720
FDA Product Code
HTC
GMDN Term
Bone fixation plate pliers
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Ortho-Med, Inc.

See all devices from Ortho-Med, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No