Catalog Number

650197

Brand Name

CT Exprès™ - Control Panel

Version/Model Number

650197

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151048,K151048

Product Code

IZQ

Product Code Name

Injector, Contrast Medium, Automatic

Public Device Record Key

cac761bd-94f8-47bc-9baa-4b0a295574b0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

37630039300112

Quantity per Package

1

Contains DI Package

17630039300118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box