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Orthomed Om 90-1865

by Ortho-Med, Inc.

Orthomed Om 90-1865 is a Class I device made by Ortho-Med, Inc., listed in FDA GUDID since 27 Oct 2026 (UDI-DI B8039018650), registry data as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB8039018650 UDI-DI Date27 Oct 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  • Withdrawn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
Self-retaining surgical retractor, reusable
Model / Ref / Catalog
OM 90-1865
Primary DI / UDI-DI
B8039018650
FDA product code
GAD
GMDN term
Self-retaining surgical retractor, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Ortho-Med, Inc.

See all devices from Ortho-Med, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)