Catalog Number

-

Brand Name

The Q-TRAK™ Subcutaneous Electrode

Version/Model Number

3400

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

P110042,P110042

Product Code

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Public Device Record Key

32e71cc3-aaa7-4fcf-93da-936eaa02f813

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-