Catalog Number

-

Brand Name

Avance®

Version/Model Number

662000

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

K122132,K122132,K122132,K122132,K122132

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

310690e4-e55b-434d-bb62-1c1477073432

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Package DI Number

07323190023226

Quantity per Package

6

Contains DI Package

07323190023233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-