Catalog Number

42671

Brand Name

Barrier

Version/Model Number

42671-01

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

952e10e3-4e5e-4e73-94bc-b40ed09f9508

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

07323190043330

Quantity per Package

4

Contains DI Package

07323190043347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-