Catalog Number

4235

Brand Name

Barrier

Version/Model Number

4235-00

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)

-

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

80cc5e71-f0ad-4876-be0b-a8595e634c4a

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

07332430084804

Quantity per Package

12

Contains DI Package

07332430084798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-