Catalog Number

SJS-PT-J

Brand Name

MEDRAD® Stellant Sterile Disposable Syringe

Version/Model Number

SJS-PT-J

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

f497a27f-fe97-49c4-9316-1923b94344c9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 20, 2018

Package DI Number

40616258009894

Quantity per Package

50

Contains DI Package

00616258009896

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-