Catalog Number

5872892

Brand Name

Allia

Version/Model Number

IGS 5

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

0b743cb5-0509-4f98-b7d4-709113581e6e

Public Version Date

April 21, 2022

Public Version Number

1

DI Record Publish Date

April 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-