Catalog Number

-

Brand Name

winner

Version/Model Number

604-007415

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"

Yes

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

ef3b2189-7ff2-4b66-98f1-25f83eae025c

Public Version Date

May 24, 2022

Public Version Number

1

DI Record Publish Date

May 16, 2022

Package DI Number

26941094025013

Quantity per Package

20

Contains DI Package

16941094025016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box