Triad Combonation Unit

GUDID 00089518000696

The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or Tinnitus.

GENERAL HEARING INSTRUMENT, INC.

Behind-the-ear air-conduction tinnitus masker
Primary Device ID00089518000696
NIH Device Record Key1264fc57-86b7-4deb-8dac-8c552c4f4f86
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriad Combonation Unit
Version Model NumberTriad Combo,OTE,10A,Digital,Polytube,Black,Left
Company DUNS131229197
Company NameGENERAL HEARING INSTRUMENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com
Phone1-800-824-3021
Emailcustomercare@generalhearing.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100089518000696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLWMasker, Tinnitus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-29

On-Brand Devices [Triad Combonation Unit]

00089518000771The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000764The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000757The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000740The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000733The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000726The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000719The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000702The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000696The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000689The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000672The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000665The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000658The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000641The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000634The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000627The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000610The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000603The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000597The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000580The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000573The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000566The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000559The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000542The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000535The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000528The Triad Combination Unit is a programmable advanced digital signal processing system incorpora
00089518000511The Triad Combination Unit is a programmable advanced digital signal processing system incorpora

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