DEVICE: Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System (05055715612647)
Device Identifier (DI) Information
Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
SG-HBL-90-18-A13-20
In Commercial Distribution
LOMBARD MEDICAL LIMITED
SG-HBL-90-18-A13-20
In Commercial Distribution
LOMBARD MEDICAL LIMITED
Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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); it does not contain anticoagulants or pharmaceuticals that prevent narrowing of the vessels. 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 in two designs: 1) a single tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
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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 [?] |
---|---|
P110032 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
acec7663-bd6c-4b13-ac43-f817caab0ee4
January 10, 2023
7
April 29, 2015
January 10, 2023
7
April 29, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+44 1235750800
kirsty.cook@lombardmedical.com
kirsty.cook@lombardmedical.com