Catalog Number

DYNJINTROPL11

Brand Name

Peel-away introducer set

Version/Model Number

DYNJINTROPL11

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

K073100,K073100

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

c4b6f4c6-6e83-44c7-994e-263f5a7e3a07

Public Version Date

September 13, 2021

Public Version Number

5

DI Record Publish Date

November 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-