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Device Explorer · FDA GUDID · GMDN 46777

Aortoiliac 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 pharmaceu

US‑registered devices1,458in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Lombard Medical Limited66846%
Cook Incorporated22515%
Medtronic, Inc.19513%
Endologix Llc16111%
Bolton Medical Inc.866%
W. L. Gore & Associates, Inc.816%
Trivascular, Inc.423%

Top labelers

CompanyDevicesShare
Lombard Medical Limited66846%
Cook Incorporated22515%
Medtronic, Inc.19513%
Endologix Llc16111%
Bolton Medical Inc.866%
W. L. Gore & Associates, Inc.816%
Trivascular, Inc.423%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Aorfix AAA Stent Graft Body with Aorflex DeliverAorfix AAA Stent Graft Distal Extender with AorfAorfix AAA Stent Graft Plug In Leg with Aorflex Aorfix AAA Stent Graft Converter with Aorflex DeAorfix AAA Stent Graft Proximal Extender with AoOvation iX Iliac Stent GraftAlto™ Abdominal Stent Graft SystemCustomSeal KitAutoinjector 2TREO Abdominal Stent-Graft SystemZenithAFX2 Bifurcated Endograft SystemVela Proximal Endograft SystemAFX Endovascular AAA SystemEndurant® IIEndurant® IIs

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment1,371
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT588

GMDN & GCC registration

  • GMDN code 46777 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 726Catheter Gauge (French) · 281Length (Millimeter) · 253Length (Centimeter) · 163Stent Diameter (Millimeter) · 76Stent Length (Millimeter) · 45

Use these as the dimensions to specify in a tender line.

How many aortoiliac endovascular stent-graft products are registered in the US?

1,458 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aortoiliac endovascular stent-graft", from 7 companies. The largest labeler is Lombard Medical Limited with 46% of records.

Which FDA product codes apply?

MIH (System, Endovascular Graft, Aortic Aneurysm Treatment), MIH (SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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