Duns Number:008965063
Device Description: Contact Lens Case intended for storage of soft (hydrophilic) rigid gas permeable (RPG) or Contact Lens Case intended for storage of soft (hydrophilic) rigid gas permeable (RPG) or hard contact lenses during chemical disinfection.
Catalog Number
156705
Brand Name
Well at Walgreens
Version/Model Number
68013WG2
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
a6ab9f3c-5275-4f87-b596-7601055bfec2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 05, 2016
Package DI Number
10023185002215
Quantity per Package
6
Contains DI Package
20023185002977
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |