Catalog Number

-

Brand Name

PREVENA RESTOR AXIO•FORM™

Version/Model Number

PRE5555

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

4b2811ec-dd96-482d-917e-5e0b4372235d

Public Version Date

November 23, 2021

Public Version Number

5

DI Record Publish Date

December 19, 2019

Package DI Number

00849554007833

Quantity per Package

5

Contains DI Package

00849554007949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5-pack