Catalog Number

-

Brand Name

Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]

Version/Model Number

EMS-11411

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

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

43f4c019-695a-47e2-a144-2445399acbe3

Public Version Date

May 20, 2021

Public Version Number

1

DI Record Publish Date

May 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-