UHP 2.0 Color Cap

GUDID 07630016843105

Onyx

Advanced Bionics AG

Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil Cochlear implant/auditory brainstem implant coil

• Primary Device ID: 07630016843105
• NIH Device Record Key: 2586b1d7-e622-4cc9-bb35-f3c505a30511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UHP 2.0 Color Cap
• Version Model Number: CI-7128-BLK
• Company DUNS: 485262658
• Company Name: Advanced Bionics AG
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com
• Phone: +1(661)362-1400
• Email: xxx@xxx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 55 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630016843105 [Primary]
GS1	07630016863370 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960058

FDA Product Code

• MCM: Implant, Cochlear

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-05
• Device Publish Date: 2018-05-14

On-Brand Devices [UHP 2.0 Color Cap ]

• 07630016853654: Caribbean Pirate
• 07630016853609: Ruby
• 07630016843136: Dark Sienna Metallic
• 07630016843105: Onyx
• 07630016843099: Sand Beige
• 07630016843075: Chestnut
• 07630016843068: Princess Pink
• 07630016842825: Silver Gray
• 07630016842818: Petrol
• 07630016842801: Velvet Black
• 07630016842542: Alpine White