Catalog Number

-

Brand Name

winner medical

Version/Model Number

604-006928

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

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

56ecd94b-641a-4099-be77-7133569909aa

Public Version Date

August 31, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2020

Package DI Number

06941094021844

Quantity per Package

20

Contains DI Package

06941094021851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box