Duns Number:008965063
Device Description: Soft Contact Lens Saline Solution, Two 12 FL OZ Bottles
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
156829
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
17318cb9-613b-4b9c-b8fa-b501261f7a7d
Public Version Date
September 27, 2018
Public Version Number
1
DI Record Publish Date
August 27, 2018
Package DI Number
10311917143573
Quantity per Package
12
Contains DI Package
00311917143576
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 |