Catalog Number

-

Brand Name

Powerwand

Version/Model Number

80701B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 2017

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OFF

Product Code Name

Central venous catheter tray

Public Device Record Key

8f180456-8f7f-4fd8-9c6f-4abeffc7a558

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

March 29, 2017

Package DI Number

20809160142247

Quantity per Package

10

Contains DI Package

10809160142240

Package Discontinue Date

July 21, 2007

Package Status

Not in Commercial Distribution

Package Type

-