Autoinjector 2 TV-AI01-N

GUDID M701TVAI01N1

The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved.

ENDOLOGIX, INC.

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• Primary Device ID: M701TVAI01N1
• NIH Device Record Key: b6753b7a-5356-4d0f-a134-3ba47511278a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autoinjector 2
• Version Model Number: TV-AI01-N
• Catalog Number: TV-AI01-N
• 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: true
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M701TVAI01N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120006

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: 2
• Public Version Date: 2020-12-21
• Device Publish Date: 2020-11-04

On-Brand Devices [Autoinjector 2]

• M701TVAI01N1: The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjecto
• 00850007370398: "The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinject