SYNCHRONY 2 36704

GUDID 09008737366759

Mi1250 SYNCHRONY 2 PIN Compressed

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 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 ID09008737366759
NIH Device Record Key8f5af469-4831-4a50-a3d5-92de918ab553
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNCHRONY 2
Version Model Number36675
Catalog Number36704
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

Operating and Storage Conditions

Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
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 -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737366759 [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 Date2019-07-08
Device Publish Date2019-06-28

On-Brand Devices [SYNCHRONY 2]

09008737371753Mi1250 SYNCHRONY 2 FLEX20
09008737371746Mi1250 SYNCHRONY 2 PIN FLEX20
09008737369026Mi1250 SYNCHRONY 2 FLEX26
09008737369019Mi1250 SYNCHRONY 2 PIN FLEX26
09008737366827Mi1250 SYNCHRONY 2 FLEX28
09008737366810Mi1250 SYNCHRONY 2 PIN FLEX28
09008737366803Mi1250 SYNCHRONY 2 FLEX24
09008737366797Mi1250 SYNCHRONY 2 PIN FLEX24
09008737366780Mi1250 SYNCHRONY 2 FLEXSOFT
09008737366773Mi1250 SYNCHRONY 2 PIN FLEXSOFT
09008737366766Mi1250 SYNCHRONY 2 Compressed
09008737366759Mi1250 SYNCHRONY 2 PIN Compressed
09008737366742Mi1250 SYNCHRONY 2 Medium
09008737366735Mi1250 SYNCHRONY 2 PIN Medium
09008737366728Mi1250 SYNCHRONY 2 Standard
09008737366711Mi1250 SYNCHRONY 2 PIN Standard
09008737395490Mi1250 SYNCHRONY 2 FLEX20 S-Vector Magnet
09008737395483Mi1250 SYNCHRONY 2 PIN FLEX20 S-Vector Magnet
09008737395476Mi1250 SYNCHRONY 2 FLEX26 S-Vector Magnet
09008737395469Mi1250 SYNCHRONY 2 PIN FLEX26 S-Vector Magnet
09008737395452Mi1250 SYNCHRONY 2 FLEX28 S-Vector Magnet
09008737395445Mi1250 SYNCHRONY 2 PIN FLEX28 S-Vector Magnet
09008737395438Mi1250 SYNCHRONY 2 FLEX24 S-Vector Magnet
09008737395421Mi1250 SYNCHRONY 2 PIN FLEX24 S-Vector Magnet
09008737395414Mi1250 SYNCHRONY 2 FLEXSOFT S-Vector Magnet
09008737395407Mi1250 SYNCHRONY 2 PIN FLEXSOFT S-Vector Magnet
09008737395391Mi1250 SYNCHRONY 2 Compressed S-Vector Magnet
09008737395384Mi1250 SYNCHRONY 2 PIN Compressed S-Vector Magnet
09008737395377Mi1250 SYNCHRONY 2 Medium S-Vector Magnet
09008737395360Mi1250 SYNCHRONY 2 PIN Medium S-Vector Magnet
09008737395353Mi1250 SYNCHRONY 2 Standard S-Vector Magnet
09008737395346Mi1250 SYNCHRONY 2 PIN Standard S-Vector Magnet

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