SYNCHRONY

GUDID 09008737093983

COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve

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

Cochlear implant system
Primary Device ID09008737093983
NIH Device Record Key174bc602-5ee9-473b-832c-5a3ce05602e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNCHRONY
Version Model NumberMi1200 SYNCHRONY +Medium
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

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
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737093983 [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 Number4
Public Version Date2021-10-19
Device Publish Date2015-02-28

On-Brand Devices [SYNCHRONY]

09008737366186Mi1200 SYNCHRONY PIN +FLEX26
09008737366179Mi1200 SYNCHRONY +FLEX26
09008737327095COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737327088COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737094089COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737094058COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737094041COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737094034Mi1200 SYNCHRONY PIN +FLEXSOFT
09008737094027Mi1200 SYNCHRONY +FLEXSOFT
09008737094010COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737094003COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737093990COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737093983COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737093976COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737093969COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737093952COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve
09008737078829Mi1200 SYNCHRONY PIN +FLEX20
09008737078805Mi1200 SYNCHRONY +FLEX20

Trademark Results [SYNCHRONY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNCHRONY
SYNCHRONY
97025117 not registered Live/Pending
Meyer Intellectual Properties Limited
2021-09-13
SYNCHRONY
SYNCHRONY
90762495 not registered Live/Pending
Synapse Biomedical, Inc.
2021-06-08
SYNCHRONY
SYNCHRONY
90599636 not registered Live/Pending
Trilogy Pro Services, LLC
2021-03-24
SYNCHRONY
SYNCHRONY
90175440 not registered Live/Pending
Stereotaxis, Inc.
2020-09-11
SYNCHRONY
SYNCHRONY
90052441 not registered Live/Pending
JEOL Ltd.
2020-07-14
SYNCHRONY
SYNCHRONY
88717055 not registered Live/Pending
Boston Scientific Scimed, Inc.
2019-12-05
SYNCHRONY
SYNCHRONY
88160676 not registered Live/Pending
Accuray Incorporated
2018-10-18
SYNCHRONY
SYNCHRONY
88132182 not registered Live/Pending
Oscilloscape, LLC
2018-09-26
SYNCHRONY
SYNCHRONY
87599480 not registered Live/Pending
Meyer Manufacturing Company Limited
2017-09-07
SYNCHRONY
SYNCHRONY
87117647 5728268 Live/Registered
Trane International Inc.
2016-07-27
SYNCHRONY
SYNCHRONY
87069217 not registered Live/Pending
Boston Scientific Scimed, Inc.
2016-06-13
SYNCHRONY
SYNCHRONY
86606113 4962711 Live/Registered
Tangent Communications, Inc.
2015-04-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.