Catalog Number

-

Brand Name

INNOVA

Version/Model Number

IGS 3 001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181403

Product Code

IZI

Product Code Name

System, x-ray, angiographic

Public Device Record Key

0a1c4781-8bca-49e7-92d0-2541427418c7

Public Version Date

February 11, 2020

Public Version Number

1

DI Record Publish Date

February 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-