Catalog Number

-

Brand Name

CDC

Version/Model Number

F405-620CD

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 07, 2017

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)

-

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

dc5f9529-2f8d-49d1-a330-79c2a6e6832a

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

March 06, 2017

Package DI Number

10023185001270

Quantity per Package

12

Contains DI Package

20023185001703

Package Discontinue Date

July 07, 2017

Package Status

Not in Commercial Distribution

Package Type

Case