Primary Device ID | 09008737318628 |
NIH Device Record Key | 15c762e5-d597-4f3b-921c-f534f6910b64 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | MAESTRO 6.0 Software Package |
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 | |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 09008737318628 [Primary] |
MCM | IMPLANT, COCHLEAR |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-01-27 |
Device Publish Date | 2015-02-28 |
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09008737525293 - SAMBA 2 Hi AP unit, left | 2023-06-20 Audio Processor |
09008737525309 - SAMBA 2 Lo AP unit, right | 2023-06-20 Audio Processor |
09008737525316 - SAMBA 2 Lo AP unit, left | 2023-06-20 Audio Processor |