Ovation iX Iliac Stent Graft TV-IL1428140-J

GUDID 00850007370091

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.

Endologix, Inc.

Abdominal aorta endovascular stent-graft
Primary Device ID00850007370091
NIH Device Record Key2949ce2f-daeb-4de5-81f4-72d2d5ee9856
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation iX Iliac Stent Graft
Version Model NumberTV-IL1428140-J
Catalog NumberTV-IL1428140-J
Company DUNS179593652
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 Numberfalse
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

Device Dimensions

Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter
Stent Diameter14 Millimeter
Stent Diameter28 Millimeter
Catheter Working Length60 Centimeter
Outer Diameter15 Femtometer
Lumen/Inner Diameter13 Femtometer
Stent Length140 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007370091 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-10
Device Publish Date2023-03-02

On-Brand Devices [Ovation iX Iliac Stent Graft]

00850007370060The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
00850007370053The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
00850007370046The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
00850007370039The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
00850007370015"The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
00085000737002The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
00850007370992The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370442The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370435The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370374The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370367The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370350The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370343The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370336The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370329The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370312The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370305The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370299The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370282The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370275The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370268The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370251The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370244The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370237The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370220The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370206The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370190The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370145The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370138The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370121The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370114The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370107The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370091The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370077The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™
00850007370008The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370428The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370411The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370213The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370183The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370176The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370169The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370152The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdom
00850007370022The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™

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