Catalog Number

HT-SK001

Brand Name

Sinton Medical Products

Version/Model Number

700101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

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

K151960,K151960,K151960

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

744e104c-6191-4cfb-b7d1-2b27ed1a7e4e

Public Version Date

April 03, 2020

Public Version Number

4

DI Record Publish Date

August 15, 2018

Package DI Number

26938327902814

Quantity per Package

2

Contains DI Package

16938327902817

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

Carton