AFX Introducer System

GUDID 00818009011381

ENDOLOGIX, INC.

Haemostasis valve Haemostasis valve

• Primary Device ID: 00818009011381
• NIH Device Record Key: 77a0d180-dd07-457b-8fd8-1eaccd537ab1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFX Introducer System
• Version Model Number: S17-45
• Company DUNS: 858560477
• Company Name: ENDOLOGIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818009011381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120212

FDA Product Code

• DYB: Introducer, Catheter

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: 2020-03-05
• Device Publish Date: 2014-09-24

Devices Manufactured by ENDOLOGIX, INC.

• 00850007370022 - Ovation iX Iliac Stent Graft: 2023-07-19 The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems.
• 00850007370152 - Ovation iX Iliac Stent Graft: 2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The
• 00850007370169 - Ovation iX Iliac Stent Graft: 2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The
• 00850007370176 - Ovation iX Iliac Stent Graft: 2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The
• 00850007370183 - Ovation iX Iliac Stent Graft: 2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The
• 00850007370213 - Ovation iX Iliac Stent Graft: 2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The
• 00850007370411 - Ovation iX Iliac Stent Graft: 2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The
• 00850007370428 - Ovation iX Iliac Stent Graft: 2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The