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.

09008737421724 - MAESTRO System Software 102024-07-08Fitting Software
09008737421724 - MAESTRO System Software 102024-07-08 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 Adapters2024-03-06 Audio Processor Adapter
09008737447861 - AudioStream Adapter & Case2024-03-06 Audio Processor AudioStream Adapter
09008737525323 - SAMBA 2 BB PoM, right2023-07-13 Audio Processor
09008737525330 - SAMBA 2 BB PoM, left2023-07-13 Audio Processor
09008737525286 - SAMBA 2 Hi AP unit, right2023-06-20 Audio Processor

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