DEVICE: Aorfix AAA Stent Graft Body with Aorflex Delivery System (05055715610964)
Device Identifier (DI) Information
Aorfix AAA Stent Graft Body with Aorflex Delivery System
SG-HBB-30-126-63-18-A12-22
In Commercial Distribution
LOMBARD MEDICAL LIMITED
SG-HBB-30-126-63-18-A12-22
In Commercial Distribution
LOMBARD MEDICAL LIMITED
Aorflex AAA Stent Graft Body with Aorflex Delivery System
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Abdominal aorta endovascular stent-graft | A sterile 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 is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries. |
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
8a4bba6d-29d0-4bbd-b355-7a52cf937258
July 06, 2018
3
May 05, 2015
July 06, 2018
3
May 05, 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 |
---|---|---|---|---|---|
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