Catalog Number

017378

Brand Name

Hydraulic Controller

Version/Model Number

017378

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

-

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

-

FDA Premarket Submission

K062449,K062449

Product Code

IZQ

Product Code Name

Injector, Contrast Medium, Automatic

Public Device Record Key

1bd68062-e3c4-4cb4-a33d-c180ef9b7ac6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

37630039300389

Quantity per Package

1

Contains DI Package

17630039300385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box