Catalog Number

PRE5601

Brand Name

PREVENA RESTOR ROTO•FORM™

Version/Model Number

PRE5601

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

360f6ec1-5531-4df5-8b3c-a6ab0b1b661e

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

February 23, 2021

Package DI Number

50849554007852

Quantity per Package

1

Contains DI Package

00849554007857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-