EPi-Sense Guided Coagulation System with VisiTrax A001280

GUDID 30840143900338

3cm Guided Coagulation System Kit

ATRICURE, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 30840143900338
• NIH Device Record Key: 96971522-2406-46fb-a84e-cf7619dedc29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPi-Sense Guided Coagulation System with VisiTrax
• Version Model Number: CDK-1413
• Catalog Number: A001280
• 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

Customer Support Contacts

• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx

Device Dimensions

• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354015249 [Previous]
GS1	10840143900327 [Primary]
GS1	30840143900338 [Package]; Contains: 10840143900327; Package: box [1 Units]; In Commercial Distribution
GS1	50840143901964 [Package]; Package: case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120857

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-18
• Device Publish Date: 2021-01-08

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

• 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