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Grason-Stadler GSI 18

by Diagnostic Group LLC

Grason-Stadler GSI 18 is a Class II device made by Diagnostic Group LLC, listed in FDA GUDID since 10 Nov 2016 (UDI-DI 00810046700006), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810046700006 UDI-DI Date10 Nov 2016ListedStatusListed 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  • Withdrawn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
Grason-Stadler
Generic name
Tone audiometer
Model / reference
GSI 18
Primary DI / UDI-DI
00810046700006
FDA product code
EWO
GMDN term
Tone audiometer
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

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Other devices from Diagnostic Group LLC

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)