Catalog Number

017380

Brand Name

Remote Control

Version/Model Number

017380

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

8342bb11-d4b1-474d-a44c-e28ee5436f21

Public Version Date

June 03, 2019

Public Version Number

1

DI Record Publish Date

May 24, 2019

Package DI Number

37630039301034

Quantity per Package

1

Contains DI Package

17630039301030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX