Catalog Number

4252535-020

Brand Name

INTROCAN SAFETY®

Version/Model Number

4252535-020

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"

Yes

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

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

c186f609-ed56-4e8d-b505-fe1eb2249ad1

Public Version Date

June 10, 2022

Public Version Number

14

DI Record Publish Date

September 23, 2016

Package DI Number

04046964399015

Quantity per Package

4

Contains DI Package

04046964399008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton