Aorfix AAA Stent Graft Body with Aorflex Delivery

GUDID 05055715611848

Aorfix AAA Stent Graft Body with Aorflex Delivery System

LOMBARD MEDICAL LIMITED

Abdominal aorta endovascular stent-graft

• Primary Device ID: 05055715611848
• NIH Device Record Key: c7b59c59-0dd8-46b1-9cb0-5a7152718dcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aorfix AAA Stent Graft Body with Aorflex Delivery
• Version Model Number: SG-HBB-31-81-63-14-A12-22
• 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
• 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	05055715611848 [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

On-Brand Devices [Aorfix AAA Stent Graft Body with Aorflex Delivery ]

• 05055715637763: Proximal Converter Graft with Aorflex Delivery System
• 05055715637749: Proximal Converter Graft with Aorflex Delivery System
• 05055715637480: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637473: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637466: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637459: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637442: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637435: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637428: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637411: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637404: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637398: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637381: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637374: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637367: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637350: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637343: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637336: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637329: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637312: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637305: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637299: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637282: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637275: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637268: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637251: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715637244: Aorflex AAA Stent Graft Body with Aorflex Delivery System
• 05055715612173: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612166: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612159: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612142: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612135: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612128: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612111: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612104: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612098: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612081: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612074: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612067: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612050: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612043: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612036: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612029: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612012: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715612005: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715611992: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715611985: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715611978: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715611961: Aorfix AAA Stent Graft Body with Aorflex Delivery System
• 05055715611954: Aorfix AAA Stent Graft Body with Aorflex Delivery System