DEVICE: Cochlear™ Nucleus® Non-magnetic Cassette (09321502039420)

Device Identifier (DI) Information

Cochlear™ Nucleus® Non-magnetic Cassette
P782484
In Commercial Distribution
P782484
COCHLEAR LIMITED
09321502039420
GS1

1
750551194 *Terms of Use
N/A
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Device Characteristics

MR Conditional
No
Yes
Yes
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 183
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

5779452c-ca93-402a-9e87-f533adec999e
July 22, 2024
3
July 12, 2019
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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

[?]
No
No
Yes
Yes
No CLOSE

Customer Contact

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