MRI Antenna Coil Cover

GUDID 07630016849503

Advanced Bionics AG

Cochlear implant implantable magnet MRI shield

• Primary Device ID: 07630016849503
• NIH Device Record Key: dd83888a-5321-44cc-83d0-8e5a70b43d80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRI Antenna Coil Cover
• Version Model Number: CI-7521
• Company DUNS: 485262658
• Company Name: Advanced Bionics AG
• 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: 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: (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	07630016849503 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-03
• Device Publish Date: 2016-09-07

On-Brand Devices [MRI Antenna Coil Cover]

• 07630016857751: CI-7521
• 07630016849503: CI-7521
• 07630016826313: CI-7521