OPUS 2 36387

GUDID 09008737363871

OPUS 2 Control Unit blue, Service Pool (SP)

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/auditory brainstem implant sound processor Cochlear implant/auditory brainstem implant sound processor Cochlear implant/auditory brainstem implant sound processor Cochlear implant/auditory brainstem implant sound processor Cochlear implant/auditory brainstem implant sound processor Cochlear implant/auditory brainstem implant sound processor Cochlear implant/auditory brainstem implant sound processor

• Primary Device ID: 09008737363871
• NIH Device Record Key: aea2f330-9e31-411e-90fd-668d3bb18ccf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPUS 2
• Version Model Number: 36387
• Catalog Number: 36387
• 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 Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com
• Phone: 1-888-633-3524
• Email: implant.us@medel.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737363871 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-18
• Device Publish Date: 2019-07-10

On-Brand Devices [OPUS 2]

• 09008737363871: OPUS 2 Control Unit blue, Service Pool (SP)
• 09008737363864: OPUS 2 Control Unit ebony, Service Pool (SP)
• 09008737363857: OPUS 2 Control Unit white, Service Pool (SP)
• 09008737363840: OPUS 2 Control Unit grey, Service Pool (SP)
• 09008737363833: OPUS 2 Control Unit beige, Service Pool (SP)
• 09008737363826: OPUS 2 Control Unit anthracite, Service Pool (SP)
• 09008737092672: OPUS 2XS UpgrKit baby pink
• 09008737092665: OPUS 2XS UpgrKit baby blue
• 09008737092658: OPUS 2XS UpgrKit green
• 09008737092641: OPUS 2XS UpgrKit orange
• 09008737092634: OPUS 2XS UpgrKit creme
• 09008737092627: OPUS 2XS UpgrKit ebony
• 09008737092610: OPUS 2XS UpgrKit white
• 09008737092603: OPUS 2XS UpgrKit brown
• 09008737092597: OPUS 2XS UpgrKit red
• 09008737092580: OPUS 2XS UpgrKit blue
• 09008737092573: OPUS 2XS UpgrKit grey
• 09008737092566: OPUS 2XS UpgrKit beige
• 09008737092559: OPUS 2XS UpgrKit anthracite
• 09008737092542: OPUS 2XS ExtKit baby pink
• 09008737092535: OPUS 2XS ExtKit baby blue
• 09008737092528: OPUS 2XS ExtKit green
• 09008737092511: OPUS 2XS ExtKit orange
• 09008737092504: OPUS 2XS ExtKit creme
• 09008737092498: OPUS 2XS ExtKit ebony
• 09008737092481: OPUS 2XS ExtKit white
• 09008737092474: OPUS 2XS ExtKit brown
• 09008737092467: OPUS 2XS ExtKit red
• 09008737092450: OPUS 2XS ExtKit blue
• 09008737092443: OPUS 2XS ExtKit grey
• 09008737092436: OPUS 2XS ExtKit beige
• 09008737092429: OPUS 2XS ExtKit anthracite
• 09008737089542: OPUS 2 BP ExtKit US babypink
• 09008737089535: OPUS 2 BP ExtKit US babyblue
• 09008737089528: OPUS 2 BP ExtKit US green
• 09008737089511: OPUS 2 BP ExtKit US orange
• 09008737089504: OPUS 2 BP ExtKit US creme
• 09008737089498: OPUS 2 BP ExtKit US ebony
• 09008737089481: OPUS 2 BP ExtKit US white
• 09008737076115: OPUS 2 D Coil Baby Kit b-pink
• 09008737076108: OPUS 2 D Coil Baby Kit b-blue
• 09008737076092: OPUS 2 D Coil Baby Kit green
• 09008737076085: OPUS 2 D Coil Baby Kit orange
• 09008737076078: OPUS 2 D Coil Baby Kit creme
• 09008737076061: OPUS 2 D Coil Baby Kit ebony
• 09008737076054: OPUS 2 D Coil Baby Kit white
• 09008737076047: OPUS 2 D Coil Baby Kit brown
• 09008737076030: OPUS 2 D Coil Baby Kit grey
• 09008737076023: OPUS 2 D Coil Baby Kit blue
• 09008737076016: OPUS 2 D Coil Baby Kit red