Catalog Number

-

Brand Name

Disposable Surgical Face Mask

Version/Model Number

EL-L03

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

K202491,K202491

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

7ab73af4-30d8-40b3-93df-d20b94dc5c36

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Package DI Number

06970206822567

Quantity per Package

40

Contains DI Package

06970206822550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case