Catalog Number

SSS-LP-60-T

Brand Name

MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube

Version/Model Number

SSS-LP-60-T

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

6f1cb01d-02a0-4c49-a1bf-a1036740c115

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

40616258021926

Quantity per Package

50

Contains DI Package

00616258021928

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-