Catalog Number

71752

Brand Name

POWERWAND

Version/Model Number

W/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

9f91e9ec-985c-494f-bd45-d414466e5ed1

Public Version Date

December 20, 2019

Public Version Number

1

DI Record Publish Date

December 12, 2019

Package DI Number

10859821006756

Quantity per Package

20

Contains DI Package

00859821006759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-