Catalog Number

DMC35

Brand Name

CARDIOVASCULAR SPRING GUIDESCARDIOVASCULAR SPRING GUIDES

Version/Model Number

DMC35

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

0d8e8a0c-e239-48bb-a6a4-121f7fd22d30

Public Version Date

July 03, 2019

Public Version Number

1

DI Record Publish Date

June 25, 2019

Package DI Number

50884908141974

Quantity per Package

4

Contains DI Package

30884908141970

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box