Catalog Number

-

Brand Name

FACE MASKS

Version/Model Number

30.M1305.00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K911334,K911334

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

90923350-c673-43b8-9683-6648741b34e1

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

August 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-