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Gyrus ACMI 130438

by Gyrus Acmi, Inc.

Gyrus ACMI 130438 is a Class I device made by Gyrus Acmi, Inc., listed in FDA GUDID since 10 Sep 2018 (UDI-DI 00821925018488), 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 Number00821925018488 UDI-DI Date10 Sep 2018ListedStatusListed 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  • Withdrawn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
Gyrus ACMI
Generic name
Middle ear chisel
Model / reference
130438
Primary DI / UDI-DI
00821925018488
FDA product code
LRC
GMDN term
Middle ear chisel
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Middle ear chisel

Similar devices in this category

Other devices filed under Middle ear chisel.

Other devices from Gyrus Acmi, Inc.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)