Duns Number:062312087
Catalog Number
-
Brand Name
SOLAR SHIELD
Version/Model Number
2918017.FGX
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
HQY
Product Code Name
Sunglasses (non-prescription including photosensitive)
Public Device Record Key
35db0f80-cb5e-4014-9969-40909741cca6
Public Version Date
July 06, 2022
Public Version Number
1
DI Record Publish Date
June 28, 2022
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 | 74463 |