Catalog Number

-

Brand Name

winner medical

Version/Model Number

604-007330

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"

-

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

0c69133f-f3cc-436c-936b-ab7824875a7b

Public Version Date

August 31, 2020

Public Version Number

2

DI Record Publish Date

June 17, 2020

Package DI Number

26941094023224

Quantity per Package

20

Contains DI Package

16941094023227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton