Catalog Number

-

Brand Name

ARTIS icono biplane

Version/Model Number

11327600

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

K190768,K220432

Product Code

IZI

Product Code Name

System, x-ray, angiographic

Public Device Record Key

38e225a3-b7a5-4087-b514-ff7f6f12c192

Public Version Date

July 07, 2022

Public Version Number

5

DI Record Publish Date

January 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-