Catalog Number

P154020

Brand Name

Pro Advantage

Version/Model Number

P154020

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)

Yes

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

FQM

Product Code Name

Bandage, Elastic

Public Device Record Key

eb0892cb-91c6-4c27-a781-2c6c805d56f5

Public Version Date

October 27, 2022

Public Version Number

1

DI Record Publish Date

October 19, 2022

Package DI Number

M220P1540205

Quantity per Package

6

Contains DI Package

M220P1540203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case