Catalog Number

7449

Brand Name

RAIDER

Version/Model Number

IPN916610

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

a78cd214-19a7-428d-a125-e737cbadf3d7

Public Version Date

January 28, 2021

Public Version Number

1

DI Record Publish Date

January 20, 2021

Package DI Number

20841156108059

Quantity per Package

5

Contains DI Package

10841156108052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box