Duns Number:690680533
Catalog Number
-
Brand Name
MeniconZ (tisilfocon A) Blue
Version/Model Number
Blue
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
HQD
Product Code Name
Lens, Contact (Other Material) - Daily
Public Device Record Key
5e5b04e2-4b04-46aa-a098-0c9effeb31f1
Public Version Date
January 20, 2020
Public Version Number
3
DI Record Publish Date
June 20, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3853 |
3 | A medical device with high risk that requires premarket approval | 2 |