Duns Number:060272465
Device Description: Contact Lens Multi-Action Relief Lubricating Eye Drops for Contact Lens Wearers
Catalog Number
-
Brand Name
Clear Eyes®
Version/Model Number
CE063404, CE063104
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P880056,P880056
Product Code
LPN
Product Code Name
Accessories, Soft Lens Products
Public Device Record Key
88cae9b2-40ef-4923-877a-902826d15ba3
Public Version Date
November 06, 2020
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
00678112664771
Quantity per Package
36
Contains DI Package
00678112653218
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 14 |