AFX2 Bifurcated Endograft System

GUDID 00818009015105

ENDOLOGIX, INC.

Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated
Primary Device ID00818009015105
NIH Device Record Key6c0e46cb-0ae9-4cd9-acc8-d52d3f1fd8e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFX2 Bifurcated Endograft System
Version Model NumberBEA22-70/I20-30
Company DUNS858560477
Company NameENDOLOGIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com
Phone(949) 595-7200
EmailCustomerService@endologix.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 59 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100818009015105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-04
Device Publish Date2016-01-18

On-Brand Devices [AFX2 Bifurcated Endograft System]

00818009015198BEA22-80/I16-55
00818009015181BEA22-100/I16-55
00818009015174BEA22-80/I20-55
00818009015167BEA22-100/I20-55
00818009015150BEA22-50/I16-30
00818009015143BEA22-70/I16-30
00818009015136BEA22-90/I16-30
00818009015129BEA22-110/I16-30
00818009015112BEA22-50/I20-30
00818009015105BEA22-70/I20-30
00818009015099BEA22-90/I20-30
00818009015082BEA22-110/I20-30
00818009015075BEA22-40/I13-40
00818009015068BEA22-60/I13-40
00818009015051BEA22-80/I13-40
00818009015044BEA22-100/I13-40
00818009015037BEA22-120/I13-40
00818009015020BEA22-40/I16-40
00818009015013BEA22-60/I16-40
00818009015006BEA22-80/I16-40
00818009014993BEA22-100/I16-40
00818009014986BEA22-120/I16-40
00818009014979BEA22-40/I20-40
00818009014962BEA22-60/I20-40
00818009014955BEA22-80/I20-40
00818009014948BEA22-100/I20-40
00818009014931BEA22-120/I20-40
00818009014924BEA25-80/I16-55
00818009014917BEA25-100/I16-55
00818009014900BEA25-80/I20-55
00818009014894BEA25-100/I20-55
00818009014887BEA25-50/I16-30
00818009014870BEA25-70/I16-30
00818009014863BEA25-90/I16-30
00818009014856BEA25-110/I16-30
00818009014849BEA25-50/I20-30
00818009014832BEA25-70/I20-30
00818009014825BEA25-90/I20-30
00818009014818BEA25-110/I20-30
00818009014801BEA25-40/I13-40
00818009014795BEA25-60/I13-40
00818009014788BEA25-80/I13-40
00818009014771BEA25-100/I13-40
00818009014764BEA25-120/I13-40
00818009014757BEA25-40/I16-40
00818009014740BEA25-60/I16-40
00818009014733BEA25-80/I16-40
00818009014726BEA25-100/I16-40
00818009014719BEA25-120/I16-40
00818009014702BEA25-40/I20-40

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