Catalog Number

-

Brand Name

Avance® Solo

Version/Model Number

880050

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

K203369,K203369

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

3982ced6-a730-4e29-8e2f-82bc67576255

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Package DI Number

07323190295982

Quantity per Package

2

Contains DI Package

07323190295999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-