Catalog Number

AVA 500 SPAT L

Brand Name

MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable

Version/Model Number

AVA 500 SPAT L

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

Yes

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

b806a333-a23d-4264-b0cc-8e2a16e94bd8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10616258007738

Quantity per Package

25

Contains DI Package

00616258007731

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-