Catalog Number

94131

Brand Name

POWERWAND™ XL

Version/Model Number

Quick Kit 5Fr X 10cm Bifurcated

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

OWL

Product Code Name

Peripheral Catheter Insertion Kit

Public Device Record Key

29fb9dbc-90ad-4e8a-aa21-52d2a3c86a0e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 25, 2017

Package DI Number

20859821006548

Quantity per Package

10

Contains DI Package

10859821006541

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton