Catalog Number

662252

Brand Name

Avance

Version/Model Number

662252-01

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,K161797

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

4515a2b3-ed2d-41d3-91af-858f7826024b

Public Version Date

July 06, 2018

Public Version Number

5

DI Record Publish Date

January 12, 2017

Package DI Number

07323190193486

Quantity per Package

5

Contains DI Package

07323190047307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-