SYNCHRONY

GUDID 09008737094041

COCHLEAR IMPLANT for the electrical stimulation of the acoustic nerve

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

Cochlear implant system

• Primary Device ID: 09008737094041
• NIH Device Record Key: 99e47db8-d268-4169-aebe-bba04eac6eef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNCHRONY
• Version Model Number: Mi1200 SYNCHRONY +FLEX28
• Company DUNS: 300764032
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737094041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000025

FDA Product Code

• MCM: IMPLANT, COCHLEAR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-19
• Device Publish Date: 2015-02-28

On-Brand Devices [SYNCHRONY]

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