Primary Device ID | 09008737421724 |
NIH Device Record Key | b6a79178-eeae-4f54-8458-f33cf1694a28 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MAESTRO System Software 10 |
Version Model Number | 42172 |
Company DUNS | 300764032 |
Company Name | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com | |
Phone | 1-888-633-3524 |
implants.us@medel.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09008737421724 [Primary] |
MCM | Implant, Cochlear |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-08 |
Device Publish Date | 2024-06-30 |
09008737421724 - MAESTRO System Software 10 | 2024-07-08Fitting Software |
09008737421724 - MAESTRO System Software 10 | 2024-07-08 Fitting Software |
09008737431716 - HearCare MED-EL | 2024-05-01 Mobile application (Android) |
09008737433079 - HearCare MED-EL | 2024-05-01 Mobile application (iOS) |
09008737447854 - AudioStream & Telecoil Adapters | 2024-03-06 Audio Processor Adapter |
09008737447861 - AudioStream Adapter & Case | 2024-03-06 Audio Processor AudioStream Adapter |
09008737525323 - SAMBA 2 BB PoM, right | 2023-07-13 Audio Processor |
09008737525330 - SAMBA 2 BB PoM, left | 2023-07-13 Audio Processor |
09008737525286 - SAMBA 2 Hi AP unit, right | 2023-06-20 Audio Processor |