DEVICE: Nucleus (09321502018043)

Device Identifier (DI) Information

Nucleus
Z208288
In Commercial Distribution
Z208288
COCHLEAR LIMITED
09321502018043
GS1

1
750551194 *Terms of Use
Cochlear Nucleus CP800 Series Portable Phone Cable (2.5 mm)
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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
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FDA Product Code

[?]
Product Code Product Code Name
MCM IMPLANT, COCHLEAR
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970051 049
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 120 cm long cable
Length: 120 Centimeter
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Device Record Status

649e10db-9116-473b-8931-eb011f65c22c
April 08, 2022
4
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)523-5798
customer@cochlear.com
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