EPi-Sense Guided Coagulation System with VisiTrax

GUDID 00818354015201

Cardiac radio-frequency ablation system generator

Primary Device ID	00818354015201
NIH Device Record Key	01d97c94-1bd0-45ba-b51a-6860c604b31f
Commercial Distribution Status	In Commercial Distribution
Brand Name	EPi-Sense Guided Coagulation System with VisiTrax
Version Model Number	CDK-1411
Company DUNS	006133784
Company Name	ATRICURE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00818354015201 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	true

00818354015300	RF Coagulation Cable Kit
00818354015249	3cm Guided Coagulation System Kit
00818354015201	1cm Guided Coagulation System Kit
30840143900352	RF Coagulation Cable Kit
30840143900338	3cm Guided Coagulation System Kit
10840143904554	3 cm Guided Coagulation System Kit