DEVICE: Neuro Cochlear Implant System (03663227001952)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61462 | Hearing aid/implant system programming interface unit |
A portable, electrically-powered device intended to facilitate the wireless or wired connection of a hearing aid or implant system component (e.g., sound processor) to a computer for programming of the hearing device with patient-specific settings and sometimes assessment. It typically consists of a small unit attached to the hearing device. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCM | Implant, Cochlear |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P200021 | 007 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
982fa363-dd2e-4623-81fc-4973824d92f0
April 08, 2022
3
November 12, 2021
April 08, 2022
3
November 12, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 (888) 277-8014
info@oticonmedicalusa.com
info@oticonmedicalusa.com