DEVICE: Nucleus (09321502002776)

Device Identifier (DI) Information

Nucleus
Z50100
In Commercial Distribution
Z50100
COCHLEAR LIMITED
09321502002776
GS1

1
750551194 *Terms of Use
CI24RE Series Non-Magnetic Plug
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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?
62602 Cochlear implant dummy magnet
A small sterile device intended to be implanted short term as a temporary replacement for a cochlear implant magnet during a magnetic resonance imaging (MRI) scan. It is typically in the same form as a cochlear implant magnet but without any magnetic material. This is a single-use 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 082
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Temperature: between -10 and 55 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c21938f9-287c-4d47-bcee-2e92b10fae2c
March 07, 2025
4
September 24, 2014
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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
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Secondary DI

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

[?]
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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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