Catalog Number

772013

Brand Name

Avance

Version/Model Number

772013-00

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)

-

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

7304c457-0267-4df3-b560-72f0ecaa6751

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 18, 2017

Package DI Number

07323190160495

Quantity per Package

10

Contains DI Package

07323190182602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-