DEVICE: Remote Control (09008737527969)
Device Identifier (DI) Information
Remote Control
52796
In Commercial Distribution
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52796
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 |
---|---|
PFO | Active Implantable Bone Conduction Hearing System |
MPV | Implant, Hearing, Active, Middle Ear, Partially Implanted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
DEN170009 | 000 |
P990052 | 026 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -29 and 60 Degrees Celsius |
Handling Environment Temperature: between -20.2 and 140 Degrees Fahrenheit |
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -29 and 60 Degrees Celsius |
Storage Environment Temperature: between -20.2 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c6ac5714-f0a8-4823-a4ed-3638c0014f30
November 14, 2022
4
September 08, 2020
November 14, 2022
4
September 08, 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