GUDID 09008737047153

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

Cochlear implant system
Primary Device ID09008737047153
NIH Device Record Key292d3ae1-b3da-4731-9a4a-dccbecc4382b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberStimulator Template SONATATi100
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

Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com
Phone+1(888)633-3524
Emailimplants.us@medel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737047153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


[09008737047153]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-19
Device Publish Date2014-09-23

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09008737461485 - SONNET Battery Pack Cover Micro Pro, Anthracite2026-03-06 Audio Processor Battery Pack Cover
09008737461492 - SONNET Battery Pack Cover Micro Pro, Ebony2026-03-06 Audio Processor Battery Pack Cover

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