Catalog Number

-

Brand Name

CARDIOVASCULAR SPRING GUIDESCARDIOVASCULAR SPRING GUIDES

Version/Model Number

MC35-JM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

7e7d5a6f-5454-4a22-94f3-3b200f8f8eaa

Public Version Date

February 03, 2021

Public Version Number

3

DI Record Publish Date

October 12, 2016

Package DI Number

50884908029241

Quantity per Package

4

Contains DI Package

30884908029247

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box