MRI Antenna Coil Cover

GUDID 07630016849503

Advanced Bionics AG

Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield Cochlear implant implantable magnet MRI shield 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