Duns Number:285420530
Device Description: Neuro ZtiCLA
Catalog Number
-
Brand Name
Neuro Cochlear Implant System
Version/Model Number
M80184
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"
-
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
P200021
Product Code
MCM
Product Code Name
Implant, Cochlear
Public Device Record Key
882d3257-da0f-4e52-a7d0-2cd7b3262991
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
October 06, 2021
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 52 |