Catalog Number

-

Brand Name

V.A.C.® GRANUFOAM™

Version/Model Number

M8275064/5

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

-

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

54696388-cc63-4920-a731-5ae1d901073c

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

May 09, 2017

Package DI Number

00878237001073

Quantity per Package

5

Contains DI Package

00878237001080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Pack