DEVICE: Nucleus (09321502017855)
Device Identifier (DI) Information
Nucleus
Z206750
In Commercial Distribution
Z206750
COCHLEAR LIMITED
Z206750
In Commercial Distribution
Z206750
COCHLEAR LIMITED
Cochlear Nucleus CP800 Series LiteWear Case
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? |
---|---|---|---|---|
32033 | Battery box |
A special container intended to be used to house batteries for protective purposes. This device will typically be portable so that the user can safely carry the power source.
|
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a1cc6831-2eef-4b08-95b9-6894bf9195a5
December 24, 2018
3
September 24, 2014
December 24, 2018
3
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:
09321502031097
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-5798
customer@cochlear.com
customer@cochlear.com