Catalog Number

-

Brand Name

SOLAR COMFORT

Version/Model Number

5291010.FGX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 20, 2023

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

1c31de88-a10e-4c44-b1a7-d38aad676624

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

June 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-