Catalog Number

DYNJINTROL8

Brand Name

Introducer set with hemostatic valve

Version/Model Number

DYNJINTROL8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2019

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

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

K090114,K090114

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

8ae75ccb-c3fb-4d06-8563-d18e35fefe8f

Public Version Date

September 13, 2021

Public Version Number

5

DI Record Publish Date

November 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-