Duns Number:008965063
Device Description: Hydrogen Peroxide Cleaning & Disinfecting Lens Care System (12 oz)
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
N/A
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
LPN
Product Code Name
Accessories, Soft Lens Products
Public Device Record Key
9954c628-df19-4b34-8874-202bedd657f1
Public Version Date
October 17, 2018
Public Version Number
2
DI Record Publish Date
August 17, 2018
Package DI Number
10311917146512
Quantity per Package
12
Contains DI Package
00311917146515
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 |