Catalog Number

-

Brand Name

Regard™

Version/Model Number

A3PMSKUL4-REG

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

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

d3cb74a2-264f-491f-95ef-c13726f258fd

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 09, 2021

Package DI Number

10326053117692

Quantity per Package

1000

Contains DI Package

00326053117695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-