DEVICE: Aorfix AAA Stent Graft Body with Aorflex Delivery System (05055715608787)

Device Identifier (DI) Information

Aorfix AAA Stent Graft Body with Aorflex Delivery System
SG-HBB-27-126-63-14-A12-22
In Commercial Distribution

LOMBARD MEDICAL LIMITED
05055715608787
GS1

1
775481088 *Terms of Use
Aorflex AAA Stent Graft Body with Aorflex Delivery System
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MIH System, Endovascular Graft, Aortic Aneurysm Treatment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P110032 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b6b6bd6b-fc75-4965-ba52-dfdc4e096649
January 10, 2023
7
May 04, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+441235750800
kirsty.cook@lombardmedical.com
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