DEVICE: FineTuner (09008737338077)
Device Identifier (DI) Information
FineTuner
33807
In Commercial Distribution
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33807
In Commercial Distribution
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Audio Processor Remote Control
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCM | Implant, Cochlear |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P000025 | 029 |
P000025 | 084 |
P000025 | 092 |
P000025 | 115 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
78977c9b-9d5b-451b-b239-2c9c00c3ab53
September 15, 2022
3
November 03, 2020
September 15, 2022
3
November 03, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-888-633-3524
implants.us@medel.com
implants.us@medel.com