Duns Number:062312574
Device Description: Contact lens case for storage of soft, rigid gas permeable, or hard contact lenses during Contact lens case for storage of soft, rigid gas permeable, or hard contact lenses during chemical disinfection only.
Catalog Number
251585
Brand Name
CVS Economate Contact Lens Case
Version/Model Number
K1010CV2
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
-
Product Code
LRX
Product Code Name
Case, Contact Lens
Public Device Record Key
ebf0d76b-ac6e-4044-b501-1424d56e995e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 21, 2016
Package DI Number
10050428324629
Quantity per Package
36
Contains DI Package
00050428324622
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
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 |