Catalog Number

501613A

Brand Name

CORDIS

Version/Model Number

501613A

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

3ca7d82d-a82a-4e64-9983-530098f41f31

Public Version Date

September 14, 2022

Public Version Number

9

DI Record Publish Date

August 01, 2016

Package DI Number

20705032009536

Quantity per Package

5

Contains DI Package

10705032009539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX