Catalog Number

-

Brand Name

CARDIOVASCULAR SPRING GUIDESCARDIOVASCULAR SPRING GUIDES

Version/Model Number

SCHON GW

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

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

08be2e61-4c66-485e-b00f-f72ccaea9bd6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 04, 2016

Package DI Number

50884908041120

Quantity per Package

100

Contains DI Package

00884908041125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box