Catalog Number

-

Brand Name

V.A.C. DERMATAC™

Version/Model Number

V.A.C. DERMATAC™

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

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

5f477c8f-3e4c-40bd-a7b3-62f24e819050

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

March 30, 2019

Package DI Number

00849554005198

Quantity per Package

10

Contains DI Package

00849554005242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Pack