SONATA 2 38551

GUDID 09008737385415

Mi1260 SONATA 2 FLEXSOFT

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 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
Primary Device ID09008737385415
NIH Device Record Key110f48c6-e8e2-43e5-a783-6b612e938689
Commercial Distribution StatusIn Commercial Distribution
Brand NameSONATA 2
Version Model Number38541
Catalog Number38551
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
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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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 -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 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
GS109008737385415 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-23
Device Publish Date2020-12-15

On-Brand Devices [SONATA 2]

09008737385453Mi1260 SONATA 2 FLEX28
09008737385446Mi1260 SONATA 2 FLEX26
09008737385439Mi1260 SONATA 2 FLEX24
09008737385422Mi1260 SONATA 2 FLEX20
09008737385415Mi1260 SONATA 2 FLEXSOFT
09008737385408Mi1260 SONATA 2 Compressed
09008737385392Mi1260 SONATA 2 Medium
09008737385385Mi1260 SONATA 2 Standard

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