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Unitron 050-5771-P474

by Unitron Hearing Division

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613389341515 UDI-DI Date23 Sep 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Unitron
Generic name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
050-5771-P474
Primary DI / UDI-DI
07613389341515
FDA product code
OSM
GMDN term
Air-conduction hearing aid, receiver-in-canal
Device class
Class II
Regulation number
874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Other devices from Unitron Hearing Division

See all devices from Unitron Hearing Division →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Expiration date: No