AFX Endovascular AAA System

GUDID 00818009013927

ENDOLOGIX, INC.

Abdominal aorta endovascular stent-graft

• Primary Device ID: 00818009013927
• NIH Device Record Key: fce975e7-eb5b-4837-9682-ee712cd3cb94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFX Endovascular AAA System
• Version Model Number: BA22-120/I13-40
• Company DUNS: 858560477
• Company Name: ENDOLOGIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com
• Phone: (949) 595-7200
• Email: CustomerService@endologix.com

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Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818009013927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040002

FDA Product Code

• MIH: System, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-04
• Device Publish Date: 2014-09-24

On-Brand Devices [AFX Endovascular AAA System]

• 00818009014245: BA28-40/I16-40
• 00818009014238: BA28-100/I20-55
• 00818009014221: BA28-80/I20-55
• 00818009014214: BA28-110/I20-30
• 00818009014207: BA28-100/I20-40
• 00818009014191: BA28-60/I20-40
• 00818009014177: BA28-40/I20-40
• 00818009014160: BA28-110/I16-30
• 00818009014153: BA28-120/I13-40
• 00818009014146: BA28-40/I13-40
• 00818009014139: BA25-100/I20-55
• 00818009014122: BA25-80/I20-55
• 00818009014115: BA25-50/I20-30
• 00818009014108: BA25-100/I20-40
• 00818009014092: BA25-60/I20-40
• 00818009014085: BA25-40/I20-40
• 00818009014078: BA25-40/I16-40
• 00818009014061: BA25-50/I16-30
• 00818009014054: BA25-120/I13-40
• 00818009014047: BA25-40/I13-40
• 00818009014030: BA22-100/I20-55
• 00818009014023: BA22-80/I20-55
• 00818009014016: BA22-100/I16-55
• 00818009014009: BA22-80/I16-55
• 00818009013996: BA22-50/I20-30
• 00818009013989: BA22-100/I20-40
• 00818009013972: BA22-60/I20-40
• 00818009013965: BA22-120/I16-40
• 00818009013958: BA22-40/I16-40
• 00818009013941: BA22-110/I16-30
• 00818009013934: BA22-50/I16-30
• 00818009013927: BA22-120/I13-40
• 00818009012630: BA28-90/I20-30
• 00818009012623: BA28-70/I20-30
• 00818009012616: BA28-50/I20-30
• 00818009012562: BA28-50/I16-30
• 00818009012296: BA22-40/I20-40
• 00818009012289: BA22-110/I20-30
• 00818009012272: BA22-90/I20-30
• 00818009012265: BA28-80/I20-40
• 00818009012241: BA25-120/I16-40
• 00818009012234: BA25-110/I20-30
• 00818009012227: BA25-90/I20-30
• 00818009012210: BA25-80/I20-40
• 00818009012197: BA25-70/I20-30
• 00818009012180: BA25-110/I16-30
• 00818009012173: BA22-80/I20-40
• 00818009012166: BA22-70/I20-30
• 00818009012159: BA22-40/I13-40
• 00818009012005: BA28-120/I16-40