DEVICE: nuance audio (08059820279778)

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Device Identifier (DI) Information
nuance audio
AW5002448
In Commercial Distribution

LUXOTTICA GROUP SPA
08059820279778
GS1

1
436825376 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47299 Air-conduction hearing aid, spectacle
A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case built into the arm(s) of spectacles. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Active false
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FDA Product Code

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Product Code Product Code Name
SCR Air-Conduction Hearing Aid Software
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K243150 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
4cdff1a8-951c-4f60-8a67-75992989cb88
February 13, 2025
1
February 05, 2025
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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
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None
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Production Identifier(s) in UDI

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No
Yes
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Yes
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Customer Contact

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No Customer Contact currently defined
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