Aorfix AAA Stent Graft Proximal Extender with Aorf

GUDID 05055715612234

Aorfix AAA Stent Graft Proximal Extender with Aorflex Delivery System

LOMBARD MEDICAL LIMITED

Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated Abdominal aorta endovascular stent-graft, non-medicated
Primary Device ID05055715612234
NIH Device Record Keyef1d83fb-0e7c-4f0c-85e0-16364848921f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAorfix AAA Stent Graft Proximal Extender with Aorf
Version Model NumberSG-HPE-29-38-A12-22
Company DUNS775481088
Company NameLOMBARD MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com
Phone+44 1235750800
Emailkirsty.cook@lombardmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055715612234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-04-29

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05055715612241Aorfix AAA Stent Graft Proximal Extender with Aorflex Delivery System
05055715612234Aorfix AAA Stent Graft Proximal Extender with Aorflex Delivery System
05055715612227Aorfix AAA Stent Graft Proximal Extender with Aorflex Delivery System
05055715612210Aorfix AAA Stent Graft Proximal Extender with Aorflex Delivery System
05055715612203Aorfix AAA Stent Graft Proximal Extender with Aorflex Delivery System
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