SOLAR SHIELD - FGX INTERNATIONAL INC.

Duns Number:062312087

Want to know more about this Product? Request more information now!


More Product Details

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

Product Characteristics

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 Details

Product Code

HQY

Product Code Name

Sunglasses (non-prescription including photosensitive)

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FGX INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 74463