Catalog Number

AVA 500 MPAT (Part 2 or 2)

Brand Name

MEDRAD® Avanta Multi-Patient Disposable Set

Version/Model Number

AVA 500 MPAT (Part 2 or 2)

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"

Yes

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

K050456,K050456

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

837b67fa-261e-4e19-bdb5-981f313731f9

Public Version Date

May 28, 2019

Public Version Number

1

DI Record Publish Date

May 20, 2019

Package DI Number

40616258010180

Quantity per Package

25

Contains DI Package

00616258010182

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-