Catalog Number

772009

Brand Name

Avance

Version/Model Number

772009-00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161797,K161797

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

6f950ed5-0ad0-4f78-b969-db4ce715eeb6

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

January 18, 2017

Package DI Number

07323190154432

Quantity per Package

10

Contains DI Package

07323190166473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-