Catalog Number

HY-50017

Brand Name

HYGITECH

Version/Model Number

HY-50017

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"

Yes

For Single-Use

Yes

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

FXP

Product Code Name

Cover, Shoe, Operating-Room

Public Device Record Key

8ce21bf3-cc32-4f4e-bfb8-1a33c1aca938

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

December 15, 2020

Package DI Number

03615140003292

Quantity per Package

10

Contains DI Package

03615140003285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton