DEVICE: FineTuner (09008737338077)

Device Identifier (DI) Information

FineTuner
33807
In Commercial Distribution

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09008737338077
GS1

1
300764032 *Terms of Use
Audio Processor Remote Control
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

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?
57885 Hearing aid/implant system remote control
A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MCM Implant, Cochlear
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P000025 029
P000025 084
P000025 092
P000025 115
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Temperature: between 32 and 122 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

78977c9b-9d5b-451b-b239-2c9c00c3ab53
September 15, 2022
3
November 03, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
1-888-633-3524
implants.us@medel.com
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