AccessGUDID - DEVICE: Ovation iX Iliac Stent Graft (00850007370145)

GUDID

Device Identifier (DI) Information

Brand Name: Ovation iX Iliac Stent Graft
Version or Model: TV-IL1410140-J
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TV-IL1410140-J
Company Name: Endologix, Inc.

Primary DI Number: 00850007370145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179593652 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46777	Abdominal aorta endovascular stent-graft	A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is typically made of a metallic outer mesh structure with an inner polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120006	001

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place.

Clinically Relevant Size

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Size Type Text
Stent Diameter: 14 Millimeter
Stent Diameter: 10 Millimeter
Catheter Working Length: 60 Centimeter
Outer Diameter: 12 Femtometer
Lumen/Inner Diameter: 10 Femtometer
Stent Length: 140 Millimeter

Device Record Status

Public Device Record Key: 180d5f15-a35a-4d64-89d7-5dfae5be4f07
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: March 02, 2023