Cannula with Guide A001311

GUDID 10840143901607

30cm Cannula with Guide

ATRICURE, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 10840143901607
• NIH Device Record Key: 6ed71781-617c-4cdb-b002-ec15c5b4c40f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannula with Guide
• Version Model Number: CSK-6131
• Catalog Number: A001311
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com
• Phone: 866-449-2342
• Email: SEhlert@atricure.com

Device Dimensions

• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143901607 [Primary]
GS1	30840143901670 [Package]; Package: box [1 Units]; In Commercial Distribution
GS1	50840143900110 [Package]; Contains: 30840143901670; Package: box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200002

FDA Product Code

• OCM: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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: 2022-10-03
• Device Publish Date: 2022-09-23

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