AtriClip® LAA Exclusion System A000967

GUDID 30840143900192

AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45

ATRICURE, INC.

Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic
Primary Device ID30840143900192
NIH Device Record Key337d2003-41fd-4435-88fa-d97bd7ddc908
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtriClip® LAA Exclusion System
Version Model NumberPRO245
Catalog NumberA000967
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

Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx

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

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354015058 [Previous]
GS110840143900198 [Primary]
GS130840143900192 [Package]
Contains: 10840143900198
Package: box [1 Units]
In Commercial Distribution
GS150840143901377 [Package]
Package: case [6 Units]
In Commercial Distribution

FDA Product Code

FZPClip, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-18
Device Publish Date2021-01-08

On-Brand Devices [AtriClip® LAA Exclusion System]

00818354015065AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 50
00818354015058AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45
00818354015041AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 40
00818354015034AtriClip® PRO2 Gilinov-Cosgrove LAA Exclusion System 35
00818354010497Selection Guide, AOD1
30840143900253Selection Guide, AOD1
30840143900208AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 50
30840143900192AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45
30840143900185AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 40
30840143900178AtriClip® PRO2 Gilinov-Cosgrove LAA Exclusion System 35
30840143907474AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 50
30840143907412AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45
30840143907351AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 40
30840143907290AtriClip® PRO2 Gilinov-Cosgrove LAA Exclusion System 35

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.