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Olympus ISM-1200390

by Gyrus Acmi, Inc.

Olympus ISM-1200390 is a Class II device made by Gyrus Acmi, Inc., listed in FDA GUDID since 8 Apr 2025 (UDI-DI 00821925046283), 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 Number00821925046283 UDI-DI Date8 Apr 2025ListedStatusListed 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  • Withdrawn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
Olympus
Generic name
Operating room equipment remote control
Model / reference
ISM-1200390
Primary DI / UDI-DI
00821925046283
FDA product code
FTA
GMDN term
Operating room equipment remote control
Device class
Class II
Regulation number
878.4580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Operating room equipment remote control

Similar devices in this category

Other devices filed under Operating room equipment remote control.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)