Catalog Number

-

Brand Name

Avance® Solo

Version/Model Number

8880050

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

b0adb40b-41ea-4b36-a415-d3fd34320aeb

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Package DI Number

07323190310654

Quantity per Package

2

Contains DI Package

07323190296705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-