Catalog Number

420

Brand Name

SJM™

Version/Model Number

420

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

NIK

Product Code Name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Public Device Record Key

64be6493-922f-488f-bf52-d513d9bce153

Public Version Date

June 07, 2019

Public Version Number

5

DI Record Publish Date

April 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-