Catalog Number

-

Brand Name

N/A

Version/Model Number

MR195150

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2020

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

a1e711c5-3af6-4102-b304-5c22410a87cc

Public Version Date

January 15, 2020

Public Version Number

2

DI Record Publish Date

July 09, 2019

Package DI Number

50884908033859

Quantity per Package

40

Contains DI Package

00884908033854

Package Discontinue Date

January 14, 2020

Package Status

Not in Commercial Distribution

Package Type

BOX