Catalog Number

ART 700 HS6

Brand Name

MEDRAD® Mark 7 Arterion Handswitch 6’ Standard

Version/Model Number

ART 700 HS6

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

-

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

K112086

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

0c7b9739-6040-4deb-91f4-dcf8e6f52986

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

April 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-