nContact RF Generator - Ground Pad Adapter Cable Kit - ATRICURE, INC.

Duns Number:006133784

Device Description: Ground Pad Adapter Cable Kit

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More Product Details

Catalog Number

-

Brand Name

nContact RF Generator

Version/Model Number

CSK-2040

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)

-

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

OCL

Product Code Name

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Device Record Status

Public Device Record Key

ac82cf81-7fc7-4657-b954-d08af3abf16a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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