AtriClip® Gillinov-Cosgrove® LAA Exclusion System A000690

GUDID 30840143911921

LAA Exclusion System, ACH145

ATRICURE, INC.

Ligation clip, metallic
Primary Device ID30840143911921
NIH Device Record Key7f0dcf02-626b-4874-a7b4-bcc392ea741f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtriClip® Gillinov-Cosgrove® LAA Exclusion System
Version Model NumberACH145
Catalog NumberA000690
Company DUNS006133784
Company NameATRICURE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com
Phone866-449-2342
EmailSEhlert@atricure.com

Device Dimensions

Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter
Length45 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110840143906121 [Previous]
GS110840143911927 [Primary]
GS130840143911921 [Package]
Contains: 10840143911927
Package: Box [1 Units]
In Commercial Distribution
GS150840143911925 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZXLeft Atrial Appendage Clip, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-26
Device Publish Date2024-02-16

On-Brand Devices [AtriClip® Gillinov-Cosgrove® LAA Exclusion System]

30840143911938LAA Exclusion System, ACH150
30840143911921LAA Exclusion System, ACH145
30840143911914LAA Exclusion System, ACH140
30840143911907LAA Exclusion System, ACH135

Trademark Results [AtriClip]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ATRICLIP
ATRICLIP
77367229 3573736 Live/Registered
AtriCure, Inc.
2008-01-09

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