Catalog Number

-

Brand Name

PREVENA PLUS™ CUSTOMIZABLE™

Version/Model Number

Prevena Plus Customizable Dressing

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

-

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

-

FDA Premarket Submission

K153199,K153199

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

968556c6-242f-4c8e-92b6-f8a41ccc82c7

Public Version Date

November 23, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

00849554005334

Quantity per Package

5

Contains DI Package

00849554005303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 PACK