Catalog Number

1456Q/92

Brand Name

Quartet™

Version/Model Number

1456Q/92

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

Yes

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

3bb336da-a67c-443e-acf8-62e0a6d85025

Public Version Date

February 05, 2021

Public Version Number

7

DI Record Publish Date

November 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-