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Starkey Halo 2 I1000 Ric 13

by Starkey Laboratories Inc. 2 variants

Starkey Halo 2 I1000 Ric 13 (64122-1) is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 15 Sep 2016 (UDI-DI 00842318105042), 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 Number00842318105042 UDI-DI Date15 Sep 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  • Withdrawn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
Starkey
Generic name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
HALO 2 I1000 RIC 13, 64122-1
Primary DI / UDI-DI
00842318105042
FDA product code
KLW, OSM
GMDN term
Air-conduction hearing aid, receiver-in-canal
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, receiver-in-canalTinnitus masking application software

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)