Catalog Number

-

Brand Name

Ernest Hemingway

Version/Model Number

H4734-TOR-49

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

4d6f5cdf-4fb3-4231-ba12-d32c570f50af

Public Version Date

August 09, 2021

Public Version Number

2

DI Record Publish Date

November 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-