Duns Number:144796497
Device Description: REFRESH RELIEVA FOR CONTACTS Lubricant Eye Drops
Catalog Number
-
Brand Name
REFRESH RELIEVA FOR CONTACTS
Version/Model Number
96632
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
K190674
Product Code
LPN
Product Code Name
Accessories, Soft Lens Products
Public Device Record Key
6203d410-1f05-4d30-a0bb-a24be6d7613e
Public Version Date
November 06, 2020
Public Version Number
2
DI Record Publish Date
August 27, 2019
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. | 3 |
3 | A medical device with high risk that requires premarket approval | 982 |
U | Unclassified | 702 |