Duns Number:285420530
Device Description: PACKING SET, NEURO2 ZTI EXCHANGE BOX C044
Catalog Number
-
Brand Name
Neuro Cochlear Implant System
Version/Model Number
181517
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
-
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
ef1b8a2e-8a0c-48e6-94b3-39885c3516b5
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
November 12, 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 |