DEVICE: Nucleus (09321502013321)
Device Identifier (DI) Information
Nucleus
Z61091
In Commercial Distribution
Z61091
COCHLEAR LIMITED
Z61091
In Commercial Distribution
Z61091
COCHLEAR LIMITED
EARHOOK (ENHANCED RETENTION) SM&LGE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
61243 | Cochlear implant/auditory brainstem implant sound processor earhook |
A small hook-shaped or formable device designed to be attached to the sound processor of a cochlear implant or auditory brainstem implant system to facilitate wearing behind the ear. It is typically made of synthetic polymer materials. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCM | IMPLANT, COCHLEAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P970051 | 028 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between -20 and 50 Degrees Celsius |
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
de361351-6ecb-435d-a5e4-794a9b9a806a
April 08, 2022
4
September 24, 2014
April 08, 2022
4
September 24, 2014
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:
09321502032056
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-5798
customer@cochlear.com
customer@cochlear.com