Catalog Number

P703020

Brand Name

Pro Advantage

Version/Model Number

P703020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

10079799-10ed-4886-b714-25860e41b6f9

Public Version Date

March 08, 2021

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

M220P7030205

Quantity per Package

500

Contains DI Package

M220P7030203

Package Discontinue Date

-

Package Status

-

Package Type

Case