Catalog Number

CSK-2030-2

Brand Name

nContact RF Generator

Version/Model Number

CSK-2030

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OCM

Product Code Name

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Public Device Record Key

afc88836-9502-4e62-9174-da5b400c6b90

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-