Catalog Number

-

Brand Name

DYEVERT™ PLUS

Version/Model Number

CMW

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

-

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

38908d94-e65e-452e-b2f4-691548a3d870

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 13, 2017

Package DI Number

00815241020003

Quantity per Package

1

Contains DI Package

00815241020478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CMW-US