Duns Number:002347102
Device Description: Lubricating and Rewetting Drops for Contacts
Catalog Number
-
Brand Name
Visine
Version/Model Number
00074300012537
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2022
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
K991620
Product Code
LPN
Product Code Name
ACCESSORIES, SOFT LENS PRODUCTS
Public Device Record Key
b106ff71-ca51-4459-8bbc-6332faa90f76
Public Version Date
April 01, 2022
Public Version Number
5
DI Record Publish Date
September 05, 2016
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 | 307 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |