HiRes™ Ultra Mock Up

GUDID 07630016829796

Advanced Bionics AG

Cochlear implant system

• Primary Device ID: 07630016829796
• NIH Device Record Key: 438b9d24-1482-4e8c-8786-a90e9e4a7816
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HiRes™ Ultra Mock Up
• Version Model Number: CI-4426
• Company DUNS: 485262658
• Company Name: Advanced Bionics AG
• Device Count: 1
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx
• Phone: (661)362-1400
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630016829796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960058

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

Devices Manufactured by Advanced Bionics AG

• 07630016894015 - M Standard battery: 2024-03-20
• 07630016894022 - M Standard battery: 2024-03-20 Precious pink
• 07630016894039 - M Standard battery: 2024-03-20 Blue ocean
• 07630016894046 - M Standard battery: 2024-03-20 Majesty purple
• 07630016875144 - 3D Magnet: 2022-04-08 Max
• 07630016875557 - 3D Headpiece Magnet Kit: 2022-04-08
• 07630016875625 - 3D Magnet: 2022-04-08 Plus
• 07630016871801 - UHP 3D: 2021-10-19