SYNCHRONY ST 33341

GUDID 09008737331917

Mi1210 SYNCHRONY ST +FLEX20

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 ID09008737331917
NIH Device Record Key428608f6-e3e0-4664-bc30-d0225ff13b85
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNCHRONY ST
Version Model Number33191
Catalog Number33341
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 -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 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 -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737331917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-13
Device Publish Date2019-06-05

On-Brand Devices [SYNCHRONY ST]

09008737331917Mi1210 SYNCHRONY ST +FLEX20
09008737331870Mi1210 SYNCHRONY ST +FLEX28
09008737331863Mi1210 SYNCHRONY ST +FLEX24
09008737331856Mi1210 SYNCHRONY ST +FLEXSOFT
09008737331849Mi1210 SYNCHRONY ST +Compressed
09008737331832Mi1210 SYNCHRONY ST +Medium
09008737331825Mi1210 SYNCHRONY ST +Standard
09008737366193Mi1210 SYNCHRONY ST +FLEX26

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