DEVICE: Nucleus (09321502022378)
Device Identifier (DI) Information
Nucleus
Z334669
In Commercial Distribution
Z334669
COCHLEAR LIMITED
Z334669
In Commercial Distribution
Z334669
COCHLEAR LIMITED
Cochlear Nucleus CR100 Series Remote Assistant (White)
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? |
---|---|---|---|---|
57885 | Hearing aid/implant system remote control |
A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCM | IMPLANT, COCHLEAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P970051 | 049 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
461bc54a-b294-4bb4-89d5-654d36e3f9bb
December 21, 2020
4
September 24, 2014
December 21, 2020
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