Catalog Number

-

Brand Name

V.A.C.ULTA™

Version/Model Number

ULTEXT0500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

-

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

de979d07-8dcf-463e-a4a9-c2ef67b5b01d

Public Version Date

February 01, 2021

Public Version Number

5

DI Record Publish Date

April 03, 2018

Package DI Number

00849554006782

Quantity per Package

5

Contains DI Package

00849554006775

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

5 Pack