Cannula with Guide A001311

GUDID 10840143901607

30cm Cannula with Guide

ATRICURE, INC.

Cardiac radio-frequency ablation system generator
Primary Device ID10840143901607
NIH Device Record Key6ed71781-617c-4cdb-b002-ec15c5b4c40f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannula with Guide
Version Model NumberCSK-6131
Catalog NumberA001311
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com

Device Dimensions

Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110840143901607 [Primary]
GS130840143901670 [Package]
Package: box [1 Units]
In Commercial Distribution
GS150840143900110 [Package]
Contains: 30840143901670
Package: box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-23

Devices Manufactured by ATRICURE, INC.

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30840143913574 - AtriClip PRO-Mini LAA Exclusion System2025-04-01 LAA Exclusion System, PROM40
30840143913581 - AtriClip PRO-Mini LAA Exclusion System2025-04-01 LAA Exclusion System, PROM45
30840143913598 - AtriClip PRO-Mini LAA Exclusion System2025-04-01 LAA Exclusion System, PROM50
30840143911761 - AtriCure Isolator Synergy EnCapture Clamp2025-03-24 Isolator Synergy EnCapture Clamp
30840143911778 - AtriClip® FLEX-Mini™ LAA Exclusion System2024-09-09 LAA Exclusion System, ACHM35
30840143911785 - AtriClip® FLEX-Mini™ LAA Exclusion System2024-09-09 LAA Exclusion System, ACHM40
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