Duns Number:006133784
Device Description: CS-3000 RF Generator
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
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
OCM
Product Code Name
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
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
Package DI Number
30840143902134
Quantity per Package
1
Contains DI Package
10840143904578
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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 |