Catalog Number

-

Brand Name

FLENTS

Version/Model Number

F405-603

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

daaa4e6e-d94d-42be-bc4c-61717c3a8116

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

20023185006036

Quantity per Package

4

Contains DI Package

00023185006032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG