UHP 2.0 Color Cap

GUDID 07630016843105

Onyx

Advanced Bionics AG

Cochlear implant system 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