DEVICE: Cochlear™ Surgical Processor CP1150S (09321502046367)

Device Identifier (DI) Information

Cochlear™ Surgical Processor CP1150S
P1648881
In Commercial Distribution
P1648881
COCHLEAR LIMITED
09321502046367
GS1

1
750551194 *Terms of Use
N/A
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Device Characteristics

MR Unsafe
No
No
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?
64984 Cochlear implant intraoperative electrophysiological transceiver
A noninvasive, electrically-powered device designed to wirelessly receive electrophysiological data (e.g., impedance, neural response) from the electrode array assembly of a cochlear implant system during implantation, and wirelessly transmit the data in real-time to an off-the-shelf computer/tablet with appropriate software installed. The data is intended for intraoperative analysis of the placement and in situ function of the implanted electrode array.
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 193
No CLOSE

Sterilization

No
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

19b7f3ae-03d8-4c01-abc5-fc5acfe8d6e8
July 22, 2024
5
July 08, 2020
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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
Yes
Yes
Yes
No CLOSE

Customer Contact

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