Catalog Number

P157002

Brand Name

PRO ADVANTAGE

Version/Model Number

P157002

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

7ab141b2-2cae-4cb3-9a46-b0f9d047b976

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

M220P1570023

Quantity per Package

100

Contains DI Package

M220P1570021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX