Catalog Number

-

Brand Name

V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING

Version/Model Number

DTGF05PKL, DTGF10PKL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K181505,K181505,K181505

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

d18cb858-5b5c-4433-9e01-3624d054bfa1

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

July 15, 2019

Package DI Number

20849554007189

Quantity per Package

10

Contains DI Package

00849554007185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Pack