Catalog Number

HER009

Brand Name

Hero

Version/Model Number

HER009

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

9a75a86f-2833-4c3c-a783-be18e49dceff

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 17, 2020

Package DI Number

10653195430090

Quantity per Package

10

Contains DI Package

00653195430093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box