Catalog Number

405428

Brand Name

SJM™

Version/Model Number

405428

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"

-

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

e7fbb6b3-4278-465c-af8d-e13b9dc0d194

Public Version Date

June 06, 2022

Public Version Number

5

DI Record Publish Date

December 03, 2015

Package DI Number

15415067021042

Quantity per Package

5

Contains DI Package

05415067021045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-