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

00f49fe3-b8b5-4de4-bed1-a1ddcef96d4a

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

Package DI Number

M220P0725245

Quantity per Package

10

Contains DI Package

M220P0725243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case