Catalog Number

-

Brand Name

PENN

Version/Model Number

1358612

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

7692cf10-0370-4072-a2cd-5b8cd97a6f88

Public Version Date

July 28, 2022

Public Version Number

1

DI Record Publish Date

July 20, 2022

Package DI Number

10031324163109

Quantity per Package

3

Contains DI Package

00031324163102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box