DEVICE: Cochlear™ Sterile Replacement Magnet (09321502046534)

Device Identifier (DI) Information

Cochlear™ Sterile Replacement Magnet
P1620873
In Commercial Distribution
P1620873
COCHLEAR LIMITED
09321502046534
GS1

1
750551194 *Terms of Use
No description.
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Device Characteristics

MR Conditional
No
No
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?
62601 Cochlear implant implantable magnet
A small, sterile, magnetic device intended to be implanted subcutaneously within the implantable component of a cochlear implant system (CIS) and to couple with a magnet in the CIS external component, to hold implantable and external components in place. It is typically a magnetized metal disc contained within a non-reactive metal (e.g., titanium) case.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
PFO Active implantable bone conduction hearing system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K191921 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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

9507f0c2-24df-4978-84f8-0bd629742791
March 17, 2021
1
March 09, 2021
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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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