DEVICE: Nucleus (09321502009577)
Device Identifier (DI) Information
Nucleus
Z60832
In Commercial Distribution
Z60832
COCHLEAR LIMITED
Z60832
In Commercial Distribution
Z60832
COCHLEAR LIMITED
FREEDOM MONITOR EARPHONES (ME1)
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? |
---|---|---|---|---|
61245 | Cochlear implant/auditory brainstem implant peripheral connector |
A device designed to be used with a cochlear implant (CI) or auditory brainstem implant system to connect the sound processor to power options (e.g., battery pack) and/or to enable connections to external devices that may be used as peripherals to the implant system; the connected devices are not included. 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 |
---|
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -20 and 50 Degrees Celsius |
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
acbac33f-1608-4767-b682-89e29624b568
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:
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