Catalog Number

A001280

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,K120857,K142084,K120857,K142084,K120857,K142084

Product Code

OCL

Product Code Name

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

Public Device Record Key

96971522-2406-46fb-a84e-cf7619dedc29

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 08, 2021

Package DI Number

30840143900338

Quantity per Package

1

Contains DI Package

10840143900327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box