Catalog Number

-

Brand Name

DYEVERT™ PLUS EZ

Version/Model Number

HV-EZ-PRS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

449dfe38-f3d2-4a38-b55e-14ffc549350b

Public Version Date

October 30, 2019

Public Version Number

2

DI Record Publish Date

November 09, 2018

Package DI Number

00815241020751

Quantity per Package

10

Contains DI Package

00815241020713

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

HV-EZ-PRS-10