SONATATI100 36614

GUDID 09008737366148

SONATATI100 +FLEX26

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

Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly Cochlear implant system electrode array assembly
Primary Device ID09008737366148
NIH Device Record Keyd3223f8f-7516-494f-b9e4-08a035e48ec7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSONATATI100
Version Model Number36614
Catalog Number36614
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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
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

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The sterilized implant may only be stored in this sterile packaging inside the Implant Box at room temperature until the stated expiry date.

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737366148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-10-19
Device Publish Date2019-08-16

On-Brand Devices [SONATATI100]

09008737366148SONATATI100 +FLEX26
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09008737049157COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
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