Duns Number:006940423
Device Description: Blue Light Glasses- Helps block potentially harmful blue light- Helps fight temporary effe Blue Light Glasses- Helps block potentially harmful blue light- Helps fight temporary effects of digital eye strain- 100% UVA-UVB Lens protection- No magnification lenses
Catalog Number
-
Brand Name
ViSAGE
Version/Model Number
702655
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQY
Product Code Name
Sunglasses (Non-Prescription Including Photosensitive)
Public Device Record Key
788a7873-321c-494d-831c-34287df2c8cb
Public Version Date
October 27, 2022
Public Version Number
3
DI Record Publish Date
April 20, 2021
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 | 94 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |