Go Prime - Beige

GUDID 00850022464591

Go Prime - Beige - In-store

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear
Primary Device ID00850022464591
NIH Device Record Key52fdbf6a-ba94-4d86-8b8c-b018b195923c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGo Prime - Beige
Version Model NumberGo Hearing
Company DUNS539177681
Company NameHEARX GROUP (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850022464591 [Primary]

FDA Product Code

QUFHearing Aid, Air-Conduction, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-20
Device Publish Date2024-02-12

On-Brand Devices [Go Prime - Beige]

00850022464591Go Prime - Beige - In-store
00810153660187Go Prime - Beige - In-store

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.