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Rexton HA STELLAR RIC 80 8C GNT

by WS Audiology USA, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number04056839076910 UDI-DI Date12 Apr 2019ListedStatusListed GUDID: not 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  • Withdrawn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
Rexton
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
HA STELLAR RIC 80 8C GNT, 10958619
Primary DI / UDI-DI
04056839076910
FDA Product Code
OSM
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class II
Regulation Number
874.3305
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Air-conduction hearing aid, behind-the-ear

Other devices from WS Audiology USA, Inc.

See all devices from WS Audiology USA, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No