Catalog Number

SSS-SPK

Brand Name

MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe &Spike

Version/Model Number

SSS-SPK

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"

Yes

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

K023183,K023183

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

182ae208-f5f2-4208-994c-0273272b3492

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

40616258022220

Quantity per Package

50

Contains DI Package

00616258022222

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-