Aorfix AAA Stent Graft Distal Extender with Aorfl

GUDID 05055715612791

Aorfix AAA Stent Graft Distal Extender with Aorflex Delivery System

LOMBARD MEDICAL LIMITED

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• Primary Device ID: 05055715612791
• NIH Device Record Key: c28a2007-9770-40e6-8dff-3aea64e7c21c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aorfix AAA Stent Graft Distal Extender with Aorfl
• Version Model Number: SG-HDE-16-82-A13-20
• Company DUNS: 775481088
• Company Name: LOMBARD MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com
• Phone: +44 1235750800
• Email: kirsty.cook@lombardmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055715612791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110032

FDA Product Code

• MIH: System, Endovascular Graft, Aortic Aneurysm Treatment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-04-29

Devices Manufactured by LOMBARD MEDICAL LIMITED

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• 05055715606424 - Aorfix AAA Stent Graft Body with Aorflex Delivery: 2018-07-06 Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715606431 - Aorfix AAA Stent Graft Body with Aorflex Delivery: 2018-07-06 Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715606448 - Aorfix AAA Stent Graft Body with Aorflex Delivery: 2018-07-06 Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715606455 - Aorfix AAA Stent Graft Body with Aorflex Delivery: 2018-07-06 Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715606462 - Aorfix AAA Stent Graft Body with Aorflex Delivery: 2018-07-06 Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715606479 - Aorfix AAA Stent Graft Body with Aorflex Delivery: 2018-07-06 Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715606486 - Aorfix AAA Stent Graft Body with Aorflex Delivery: 2018-07-06 Aorflex AAA Stent Graft Body with Aorflex Delivery System