DEVICE: Cochlear™ Surgical Processor CP1150S (09321502046367)
Device Identifier (DI) Information
Cochlear™ Surgical Processor CP1150S
P1648881
In Commercial Distribution
P1648881
COCHLEAR LIMITED
P1648881
In Commercial Distribution
P1648881
COCHLEAR LIMITED
N/A
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCM | Implant, cochlear |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P970051 | 193 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
19b7f3ae-03d8-4c01-abc5-fc5acfe8d6e8
July 22, 2024
5
July 08, 2020
July 22, 2024
5
July 08, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-5798
customer@cochlear.com
customer@cochlear.com