AFX2 Bifurcated Endograft System

GUDID 00818009014832

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 ID00818009014832
NIH Device Record Keyc113b7d5-6554-4654-a073-3ae461b0d645
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFX2 Bifurcated Endograft System
Version Model NumberBEA25-70/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 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
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100818009014832 [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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