EPi-Sense Guided Coagulation System with VisiTrax

GUDID 30840143900352

RF Coagulation Cable Kit

ATRICURE, INC.

Cardiac radio-frequency ablation system generator
Primary Device ID30840143900352
NIH Device Record Keydf81f53d-3067-4f8d-bf8b-468f468422b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPi-Sense Guided Coagulation System with VisiTrax
Version Model NumberCSK-2000
Company DUNS006133784
Company NameATRICURE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354015300 [Previous]
GS110840143900341 [Primary]
GS130840143900352 [Package]
Contains: 10840143900341
Package: box [1 Units]
In Commercial Distribution
GS150840143901988 [Package]
Package: case [108 Units]
In Commercial Distribution

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-18
Device Publish Date2021-01-08

On-Brand Devices [EPi-Sense Guided Coagulation System with VisiTrax]

00818354015300RF Coagulation Cable Kit
008183540152493cm Guided Coagulation System Kit
008183540152011cm Guided Coagulation System Kit
30840143900352RF Coagulation Cable Kit
308401439003383cm Guided Coagulation System Kit
108401439045543 cm Guided Coagulation System Kit

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