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Orthomed Om 46-0215

by Ortho-Med, Inc.

Orthomed Om 46-0215 is a Class I device made by Ortho-Med, Inc., listed in FDA GUDID since 21 Sep 2022 (UDI-DI B8034602150), 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 NumberB8034602150 UDI-DI Date21 Sep 2022ListedStatusListed 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  • Withdrawn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 lever/elevator, reusable
Model / reference
OM 46-0215
Primary DI / UDI-DI
B8034602150
FDA product code
HTE
GMDN term
Bone lever/elevator, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone lever/elevator, reusable

Other devices from Ortho-Med, Inc.

See all devices from Ortho-Med, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
Other properties (13, all answered No)