Catalog Number

-

Brand Name

V.A.C. VERAT.R.A.C. DUO™

Version/Model Number

ULTLNK0500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K100657,K100657,K100657

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

d15d1e34-24f1-491e-8c38-8cbe4b8590da

Public Version Date

September 09, 2020

Public Version Number

6

DI Record Publish Date

September 05, 2016

Package DI Number

00849554000186

Quantity per Package

5

Contains DI Package

00849554001312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 PACK