Catalog Number

405016

Brand Name

GuideRight™

Version/Model Number

405016

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

3fc62668-6bec-4fb8-8c76-63b5bba99ef1

Public Version Date

September 21, 2020

Public Version Number

4

DI Record Publish Date

December 02, 2015

Package DI Number

15415067009248

Quantity per Package

5

Contains DI Package

05415067009241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-