MAESTRO System Software 10

GUDID 09008737421724

Fitting Software

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Audiometric/hearing device software
Primary Device ID09008737421724
NIH Device Record Keyb6a79178-eeae-4f54-8458-f33cf1694a28
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAESTRO System Software 10
Version Model Number42172
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737421724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-30

Devices Manufactured by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

09008737383015 - SONNET 3 BabyWear Kit (DL) White2025-03-07 Audio Processor Accessory
09008737383022 - SONNET 3 BabyWear Kit (DL) Beige2025-03-07 Audio Processor Accessory
09008737383039 - SONNET 3 BabyWear Kit (DL) Nordic Gray2025-03-07 Audio Processor Accessory
09008737385842 - SONNET 3 BabyWear Kit (DL) Black2025-03-07 Audio Processor Accessory
09008737412180 - FineTuner Echo2025-03-06 Audio Processor Remote Control
09008737413415 - AudioKey 32025-03-06 Mobile application (iOS)
09008737413422 - AudioKey 32025-03-06 Mobile application (Android)
09008737434830 - SONNET 3 Kit (Me1710) BAT FTE Anthracite2025-03-06 Audio Processor Kit

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