Duns Number:107289657
Device Description: Multi - Purpose Solution Cleans, desinfects, removes protein daily, rinses and stores soft Multi - Purpose Solution Cleans, desinfects, removes protein daily, rinses and stores soft contact lenses.
Catalog Number
-
Brand Name
Nexus Optical
Version/Model Number
Aquanu 4 Fl Oz
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYL
Product Code Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Public Device Record Key
14a857e4-35f3-4c24-b8d0-35c8ab440ff5
Public Version Date
April 22, 2020
Public Version Number
1
DI Record Publish Date
April 14, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |