Duns Number:285420530
Device Description: Neuro Zti Fixation Screws
Catalog Number
-
Brand Name
Neuro Cochlear Implant System
Version/Model Number
M80174
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P200021
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
82ccf7db-32cf-49fe-a50e-e8e75696d8c5
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
August 27, 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 |