CustomSeal Kit TV-CS14-G

GUDID 00850007370459

The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Kit, and an Autoinjector.

Endologix, Inc.

Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft
Primary Device ID00850007370459
NIH Device Record Key231ed6c5-c499-4d26-a8a2-cd0f1e61b22f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustomSeal Kit
Version Model NumberTV-CS14-G
Catalog NumberTV-CS14-G
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

Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter
Total Volume14 Milliliter

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
GS100850007370459 [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

Devices Manufactured by Endologix, Inc.

00850007370022 - Ovation iX Iliac Stent Graft2023-07-19 The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems.
00850007370152 - Ovation iX Iliac Stent Graft2023-03-13 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 Graft2023-03-13 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 Graft2023-03-13 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 Graft2023-03-13 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 Graft2023-03-13 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 Graft2023-03-13 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 Graft2023-03-13 The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The
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