DEVICE: Serenade Tinnitus Treatment System (00861259000209)

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Device Identifier (DI) Information

Serenade Tinnitus Treatment System
900000

SOUNDCURE, INC.
00861259000209
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
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No

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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Sterilization

No
No
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 Status

In Commercial Distribution
September 01, 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
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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408-938-5745
customerservice@soundcure.com
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