Catalog Number
K9303032A
Brand Name
Nexxis
Version/Model Number
MNA-110
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
-
Product Code
DXJ
Product Code Name
DISPLAY, CATHODE-RAY TUBE, MEDICAL
Public Device Record Key
884da44d-b3b7-4e1e-809b-37b835c3842a
Public Version Date
December 20, 2018
Public Version Number
3
DI Record Publish Date
June 30, 2016
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 | 105 |
2 | A medical device with a moderate to high risk that requires special controls. | 259 |