HiRes™ Ultra CI HiFocus™ SlimJ Electrode
GUDID 07630016855696
Advanced Bionics AG
Cochlear implant system electrode array assembly| Primary Device ID | 07630016855696 |
| NIH Device Record Key | 448f5709-36ba-4cc2-8733-bcb3a62ca4fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiRes™ Ultra CI HiFocus™ SlimJ Electrode |
| Version Model Number | CI-1600-05 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(661)362-1400 |
| 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 |
| 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 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
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| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| 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 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630016855696 [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 | 2017-11-15 |
On-Brand Devices [HiRes™ Ultra CI HiFocus™ SlimJ Electrode]
| 07630016857201 | CI-1600-05 |
| 07630016855696 | CI-1600-05 |
| 07630016877988 | CI-1600-05 |
Trademark Results [HiRes]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HIRES 86321816 4681668 Live/Registered |
TOPSIL GLOBAL WAFERS A/S 2014-06-26 |
 HIRES 79214921 not registered Dead/Abandoned |
Maschinenfabrik Reinhausen GmbH 2016-07-28 |
 HIRES 79050788 3598674 Live/Registered |
Applied Materials GmbH & Co. KG 2008-02-06 |
 HIRES 78811996 3251053 Dead/Cancelled |
Seismic Ventures, Inc. 2006-02-10 |
 HIRES 78692099 3365646 Dead/Cancelled |
TA PENG HUANG 2005-08-13 |
 HIRES 78674243 3195941 Live/Registered |
DR PEPPER/SEVEN UP, INC. 2005-07-20 |
 HIRES 78510853 3271510 Dead/Cancelled |
Topsil Semiconductor Materials A/S 2004-11-03 |
 HIRES 78351647 2917467 Live/Registered |
DR PEPPER/SEVEN UP, INC. 2004-01-14 |
 HIRES 78174387 not registered Dead/Abandoned |
ADVANCED BIONICS, LLC 2002-10-15 |
 HIRES 78135779 2861301 Live/Registered |
ADVANCED BIONICS AG 2002-06-14 |
 HIRES 75697038 2418758 Dead/Cancelled |
STORA ENSO OYJ 1999-05-04 |
 HIRES 74099496 1671998 Dead/Cancelled |
Cadbury Beverages B.V. 1990-09-24 |
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