Catalog Number

-

Brand Name

Medical Imaging Solutions Intl.

Version/Model Number

200109

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170279,K170279

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

7d54efd8-ea83-44bf-b9c5-3878fbf5ce72

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Package DI Number

10850014500143

Quantity per Package

20

Contains DI Package

00850014500146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case