AtriClip® Gillinov-Cosgrove LAA Exclusion System A000644

GUDID 30840143911860

LAA Exclusion System, LAAØ35

ATRICURE, INC.

Ligation clip, metallic
Primary Device ID30840143911860
NIH Device Record Key52e084cb-acbd-4b68-b93e-8b3a99978dd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtriClip® Gillinov-Cosgrove LAA Exclusion System
Version Model NumberLAA035
Catalog NumberA000644
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

Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter

Operating and Storage Conditions

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
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110840143906725 [Previous]
GS110840143911866 [Primary]
GS130840143911860 [Package]
Contains: 10840143911866
Package: Box [1 Units]
In Commercial Distribution
GS150840143911864 [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]

30840143911891LAA Exclusion System, LAAØ50
30840143911884LAA Exclusion System, LAAØ45
30840143911877LAA Exclusion System, LAAØ40
30840143911860LAA Exclusion System, LAAØ35

Trademark Results [AtriClip]

Mark Image

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.