Catalog Number

MC150J

Brand Name

CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSCARDIOVASCULAR AND VASCULAR G

Version/Model Number

MC150J

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

355a05cd-763b-4050-908b-7a4dfd2c43e2

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

October 24, 2018

Package DI Number

50884908028039

Quantity per Package

4

Contains DI Package

30884908028035

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box