Catalog Number

72641

Brand Name

POWERWAND

Version/Model Number

ED Quick Kit 3Fr x 6cm (Custom)

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

65b2684f-f06e-4523-8d3e-ce9150ed0518

Public Version Date

April 02, 2020

Public Version Number

1

DI Record Publish Date

March 25, 2020

Package DI Number

10859821006794

Quantity per Package

10

Contains DI Package

00859821006797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton