Catalog Number

-

Brand Name

DYEVERT™ PLUS

Version/Model Number

LVOFF-PWL

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

f3e6cd11-6bc4-437a-90d1-0985e10a6855

Public Version Date

October 30, 2019

Public Version Number

3

DI Record Publish Date

November 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-