Catalog Number

-

Brand Name

Face Shield

Version/Model Number

BS0813

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

KPY

Product Code Name

Shield, Protective, Personnel

Public Device Record Key

7f911b64-bbd2-40d5-8fd0-3498562824db

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Package DI Number

10843356102625

Quantity per Package

3

Contains DI Package

00843356102628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-