DEVICE: Nucleus® (09321502050708)
Device Identifier (DI) Information
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCM | Implant, cochlear |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P970051 | 193 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
193f56ce-866c-492a-bd3a-480e4e1b59c0
August 10, 2020
1
August 01, 2020
August 10, 2020
1
August 01, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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(800)523-5798
customer@cochlear.com
customer@cochlear.com