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Gyrus ACMI 890916

by Gyrus Acmi, Inc.

Gyrus ACMI 890916 is a Class I device made by Gyrus Acmi, Inc., listed in FDA GUDID since 13 Sep 2018 (UDI-DI 00821925034082), 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 Number00821925034082 UDI-DI Date13 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  • Withdrawn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
Intranasal splint, non-biodegradable
Model / reference
890916
Primary DI / UDI-DI
00821925034082
FDA product code
LYA
GMDN term
Intranasal splint, non-biodegradable
Device class
Class I
Regulation number
874.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intranasal splint, non-bioabsorbable, animal-derived

Similar devices

Other devices filed under FDA product code LYA (SPLINT, INTRANASAL SEPTAL).

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)