Catalog Number

P072523

Brand Name

Pro Advantage

Version/Model Number

P072523

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

IPM

Product Code Name

Cover, Limb

Public Device Record Key

f862279c-2243-4214-8aa4-0ac8e12aa9d5

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Package DI Number

M220P0725235

Quantity per Package

12

Contains DI Package

M220P0725233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case