Catalog Number

P150160

Brand Name

PRO ADVANTAGE

Version/Model Number

P150160

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

0c693d83-9664-4bf7-a0c0-4a5ed0d1d52f

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

February 15, 2019

Package DI Number

M220P1501605

Quantity per Package

1200

Contains DI Package

M220P1501603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-