DEVICE: Nucleus® (09321502050708)

Device Identifier (DI) Information

Nucleus®
P1652770
In Commercial Distribution
P1652770
COCHLEAR LIMITED
09321502050708
GS1

1
750551194 *Terms of Use
Nucleus® SmartNav
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
64985 Cochlear implant intraoperative electrophysiological analysis software
A software program intended to be used with an off-the-shelf computer/tablet for the intraoperative analysis of electrophysiological data (e.g., impedance, neural response) collected from the electrode array assembly of a cochlear implant system during implantation. It is intended to assist the surgeon with regards to the placement and in situ function of the implanted electrode array.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MCM Implant, cochlear
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970051 193
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

193f56ce-866c-492a-bd3a-480e4e1b59c0
August 10, 2020
1
August 01, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)523-5798
customer@cochlear.com
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