Catalog Number

42301

Brand Name

Barrier

Version/Model Number

42301-01

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

K920108,K920108,K920108

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

d363390a-7e26-4645-b86f-16f7dad73df8

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

07323190000586

Quantity per Package

10

Contains DI Package

07323190000593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-