Duns Number:062312574
Device Description: Multi-Purpose Solution. For Soft contact lenses, Two 12 FL oz (355mL) bottles
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
851562
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)
-
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
a2a3ce8f-05e3-4715-9973-6da625326a29
Public Version Date
April 21, 2020
Public Version Number
1
DI Record Publish Date
April 13, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |