DEVICE: Samba BB, Right (09008738515606)
Device Identifier (DI) Information
Samba BB, Right
51560
Not in Commercial Distribution
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
51560
Not in Commercial Distribution
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Audio Processor Kit
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? |
---|---|---|---|---|
62209 | Bone-conduction hearing implant system sound processor/vibrator |
An electrically-powered, external device intended to compensate for impaired hearing by receiving sound waves from the environment and converting them into vibrations, which are transmitted to the inner ear via the temporal bone. It typically incorporates a microphone, transmitter/receiver and vibrator connected or magnetically coupled to vibrating implantable components (e.g., vibration transmission screw, partially-implantable abutment) for retention and transmission of vibrations to the inner ear; it may include positioning and protection devices. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PFO | Implantable Bone Conduction Hearing Aid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
DEN170009 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Humidity: less than 93 Percent (%) Relative Humidity |
Handling Environment Temperature: between -13 and 140 Degrees Fahrenheit |
Handling Environment Temperature: between -25 and 60 Degrees Celsius |
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity |
Storage Environment Temperature: between -13 and 140 Degrees Fahrenheit |
Storage Environment Temperature: between -25 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
399d75a5-aec8-4ce1-8964-48957a2b1ced
June 24, 2024
4
August 09, 2018
June 24, 2024
4
August 09, 2018
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)633-3527
implants.us@medel.com
implants.us@medel.com