Catalog Number

7449

Brand Name

RAIDER

Version/Model Number

IPN913608

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"

-

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

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

b2940f2f-27d3-40d6-94de-0cfc6e1a5cc1

Public Version Date

August 30, 2019

Public Version Number

2

DI Record Publish Date

November 08, 2018

Package DI Number

30841156101286

Quantity per Package

5

Contains DI Package

10841156101282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box