Catalog Number

0400665000

Brand Name

NA

Version/Model Number

0400665000

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

-

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

dfcbf2eb-ae44-43d0-873f-c63d20481fff

Public Version Date

April 06, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

37613154174417

Quantity per Package

12

Contains DI Package

07613154174416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack