Slim HP 3D Magnet

GUDID 07630016880568

4

Advanced Bionics AG

Cochlear implant system external magnet

• Primary Device ID: 07630016880568
• NIH Device Record Key: cf078caf-4ff7-433d-bf50-82a9cb7fc8a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slim HP 3D Magnet
• Version Model Number: CI-7525-004
• 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: 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.xxx
• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
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• Phone: +1(661)362-1400
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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840094446762 [Primary]
GS1	07630016880568 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [Slim HP 3D Magnet]

• 07630016880889: 7
• 07630016880728: 6
• 07630016880711: 5
• 07630016880568: 4
• 07630016880551: 3
• 07630016880544: 2
• 07630016880537: 1