Duns Number:750551194
Device Description: N/A
Catalog Number
P1431676
Brand Name
Cochlear™ Nucleus® CI624 cochlear implant with Slim 20 electrode
Version/Model Number
P1431676
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P970051
Product Code
MCM
Product Code Name
Implant, cochlear
Public Device Record Key
855f6d36-607f-43d5-8d29-9165b5775ff0
Public Version Date
September 10, 2021
Public Version Number
2
DI Record Publish Date
February 18, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 980 |