Catalog Number

-

Brand Name

Walgreens

Version/Model Number

443529

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)

Yes

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

969884ad-09af-4018-afc0-a4f944c3f34f

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Package DI Number

10311917217229

Quantity per Package

54

Contains DI Package

00311917217222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case