Duns Number:039634472
Device Description: Ridgid-gas-permeable corrective contact lens, daily ware
Catalog Number
-
Brand Name
FLUOREX®300UV
Version/Model Number
FLX300UV
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K991780
Product Code
HQD
Product Code Name
Lens, Contact (Other Material) - Daily
Public Device Record Key
1662b8d0-0b02-4f64-b256-36447c080984
Public Version Date
July 17, 2018
Public Version Number
5
DI Record Publish Date
September 20, 2017
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. | 6 |