Catalog Number

017356

Brand Name

FastLoad™ MR Syringe Pack

Version/Model Number

017356

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

K062449,K062449

Product Code

IZQ

Product Code Name

Injector, Contrast Medium, Automatic

Public Device Record Key

bcf2f45e-b4db-41a7-87a6-9ecf5c24b999

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

October 20, 2017

Package DI Number

37630039300860

Quantity per Package

50

Contains DI Package

17630039300866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box