Catalog Number

-

Brand Name

COUGAR® XT

Version/Model Number

CGRXT190HJ

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"

-

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

K140695,K140695

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

cef703a1-ccaa-4fb1-85d7-e6c3de620a7a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 03, 2016

Package DI Number

20643169452828

Quantity per Package

5

Contains DI Package

00643169452824

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK