Duns Number:006961700
Device Description: Soft Contact Lens Disinfecting Solution, Two 12 FL OZ Bottles, 1 Lens Case
Catalog Number
FCP-4278A
Brand Name
up & up advanced multi-purpose solution
Version/Model Number
630345
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
LYL
Product Code Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Public Device Record Key
1bed7ab7-0d81-4724-8e53-d4bfe8975324
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 05, 2020
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 | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |
U | Unclassified | 12 |