Catalog Number

-

Brand Name

V.A.C.® GRANUFOAM™

Version/Model Number

320913

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 07, 2017

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

-

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

51238c97-d7af-4307-a105-ffec58b439db

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

September 05, 2016

Package DI Number

00849554000858

Quantity per Package

5

Contains DI Package

00849554002579

Package Discontinue Date

April 07, 2017

Package Status

Not in Commercial Distribution

Package Type

5 PACK