Catalog Number

71697

Brand Name

POWERWAND

Version/Model Number

Dressing Change Kit with StatLock

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OXQ

Product Code Name

Dressing Change Tray

Public Device Record Key

6ba743ef-d3b2-4f35-b153-4b99dca2d9ae

Public Version Date

July 22, 2019

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

20859821006371

Quantity per Package

20

Contains DI Package

10859821006374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton