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Unitron 050-6258-P644

by Unitron Hearing Division

Unitron 050-6258-P644 is a Class II device made by Unitron Hearing Division, listed in FDA GUDID since 28 Mar 2020 (UDI-DI 07613389344196), 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 Number07613389344196 UDI-DI Date28 Mar 2020ListedStatusListed 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  • Withdrawn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
Unitron
Generic name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
050-6258-P644
Primary DI / UDI-DI
07613389344196
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

Related devices

Category: Air-conduction hearing aid, receiver-in-canal

Similar devices in this category

Other devices filed under Air-conduction hearing aid, receiver-in-canal.

Other devices from Unitron Hearing Division

See all devices from Unitron Hearing Division →

Properties

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