DEVICE: Triad Combonation Unit (00089518000757)

Device Identifier (DI) Information

Triad Combonation Unit
Triad Combo,Custom,Left
In Commercial Distribution

GENERAL HEARING INSTRUMENT, INC.
00089518000757
GS1

1
131229197 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
In-the-ear air-conduction tinnitus masker, digital A battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). It typically consists of a miniature sound generator, contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)], that delivers the noise to the eardrum through air. The microphone in some types may measure the level of the background noise and adjust accordingly the masking signal. The digital design of the device allows for the introduction of new tinnitus masking software programs.
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FDA Product Code

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Product Code Product Code Name
KLW Masker, Tinnitus
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K974751 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3d9e4fe6-7054-492d-ab62-3ff4f3fc11e1
July 06, 2018
3
September 29, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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1-800-824-3021
customercare@generalhearing.com
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