Triad Combonation Unit

GUDID 00089518000658

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.

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• Primary Device ID: 00089518000658
• NIH Device Record Key: ff54f835-8e02-4a51-ad88-d2ae5a96b00b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triad Combonation Unit
• Version Model Number: Triad Combo,OTE,10A,Digital,Polytube,Beige,Pair
• Company DUNS: 131229197
• Company Name: GENERAL HEARING INSTRUMENT, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00089518000658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974751

FDA Product Code

• KLW: Masker, Tinnitus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [Triad Combonation Unit]

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