nContact RF Generator - CS-3000 RF Generator - ATRICURE, INC.

Duns Number:006133784

Device Description: CS-3000 RF Generator

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More Product Details

Catalog Number

CSK-320-1

Brand Name

nContact RF Generator

Version/Model Number

CSK-320

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OCM

Product Code Name

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Device Record Status

Public Device Record Key

51d7ce73-38db-4cc2-877e-eaeff8429548

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 24, 2021

Additional Identifiers

Package DI Number

30840143902134

Quantity per Package

1

Contains DI Package

10840143904578

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"ATRICURE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 129
2 A medical device with a moderate to high risk that requires special controls. 133
3 A medical device with high risk that requires premarket approval 11