Duns Number:006133784
Device Description: 3 cm Guided Coagulation System Kit
Catalog Number
CDK-1413-3
Brand Name
EPi-Sense Guided Coagulation System with VisiTrax
Version/Model Number
CDK-1413
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
K120857,K142084,P200002,K120857,K142084,P200002,K120857,K142084,P200002
Product Code
OCM
Product Code Name
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Public Device Record Key
1239ebde-ff20-4167-a932-e28f30532c9b
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 24, 2021
Package DI Number
30840143903827
Quantity per Package
1
Contains DI Package
10840143904554
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 |