Catalog Number

-

Brand Name

V.A.C.INSTILL®

Version/Model Number

M6275413/5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

7440f7be-7daf-4191-9598-562391d8797f

Public Version Date

February 01, 2021

Public Version Number

6

DI Record Publish Date

November 02, 2016

Package DI Number

00878237001417

Quantity per Package

5

Contains DI Package

00878237001639

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

5 PACK