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.

Abdominal aorta endovascular stent-graft
Primary Device IDM701TVAI01N1
NIH Device Record Keyb6753b7a-5356-4d0f-a134-3ba47511278a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoinjector 2
Version Model NumberTV-AI01-N
Catalog NumberTV-AI01-N
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 Batchtrue
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM701TVAI01N1 [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 Number2
Public Version Date2020-12-21
Device Publish Date2020-11-04

On-Brand Devices [Autoinjector 2]

M701TVAI01N1The 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

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