Catalog Number

72627

Brand Name

POWERWAND

Version/Model Number

Quick Kit 3Fr X 6cm

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

K162322,K162322

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

1cc80955-5e24-4f47-84a2-af9533671f26

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 27, 2017

Package DI Number

10859821006671

Quantity per Package

10

Contains DI Package

00859821006674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton