Sontro Self-Fitting OTC Hearing Aids

GUDID 00850016231109

Air-conduction hearing aid, receiver-in-canal

Primary Device ID	00850016231109
NIH Device Record Key	2ec9888e-c063-47b1-840a-6ff186337743
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sontro Self-Fitting OTC Hearing Aids
Version Model Number	990035-SWH
Company DUNS	050441605
Company Name	Soundwave Hearing, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00850016231109 [Primary]

QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Steralize Prior To Use	false
Device Is Sterile	false

00850016231109	BEIGE/990035-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model AI-S); self-fit, streaming,
00850016231000	GREY/990030-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model AI-S); self-fit, streaming,