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Audion AET-100

by Stryker Corp.

Audion AET-100 is a Class II device made by Stryker Corp., listed in FDA GUDID since 3 Jun 2022 (UDI-DI 00850002250428), 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 Number00850002250428 UDI-DI Date3 Jun 2022ListedStatusListed 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  • Withdrawn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
Audion
Generic name
Eustachian catheter, single-use
Model / reference
AET-100
Primary DI / UDI-DI
00850002250428
FDA product code
PNZ
GMDN term
Eustachian catheter, single-use
Device class
Class II
Regulation number
874.4180
GUDID distribution status
In Commercial Distribution

Related devices

Category: Eustachian catheter, single-use

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)