Catalog Number

76416

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

-

Product Code

OWL

Product Code Name

Peripheral Catheter Insertion Kit

Public Device Record Key

e9a9c166-ba6e-490b-8ca4-af3d5390bee8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 28, 2017

Package DI Number

20859821006494

Quantity per Package

10

Contains DI Package

10859821006497

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton