Catalog Number

404580

Brand Name

GuideRight™

Version/Model Number

404580

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

2877802a-a086-46a4-ac41-4998dcd04545

Public Version Date

September 21, 2020

Public Version Number

4

DI Record Publish Date

June 23, 2015

Package DI Number

15414734013298

Quantity per Package

5

Contains DI Package

05414734013291

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-