Catalog Number

-

Brand Name

Medichoice

Version/Model Number

PG4-2073

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"

Yes

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

63f5f491-6edc-44e6-8de1-b7d8b4f573f8

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

50885632100596

Quantity per Package

6

Contains DI Package

10885632100598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-