Endurant® IIs

GUDID 00763000306328

STENT GRAFT ESBF2514C103E ENDUR IIS BIF

MEDTRONIC, INC.

Abdominal aorta endovascular stent-graft

• Primary Device ID: 00763000306328
• NIH Device Record Key: 563f275f-3840-4d85-92ea-65effcfbb1df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endurant® IIs
• Version Model Number: ESBF2514C103E
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the system at room temperature in a dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000306328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100021

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-21

On-Brand Devices [Endurant® IIs]

• 00643169439993: Stent Graft ESBF2314C103E Endur IIs BIF
• 00643169439986: Stent Graft ESBF2514C103E Endur IIs BIF
• 00643169439979: Stent Graft ESBF2814C103E Endur IIs BIF
• 00643169439962: Stent Graft ESBF3214C103E Endur IIs BIF
• 00643169439955: Stent Graft ESBF3614C103E Endur IIs BIF
• 00763000306359: STENT GRAFT ESBF3614C103E ENDUR IIS BIF
• 00763000306342: STENT GRAFT ESBF3214C103E ENDUR IIS BIF
• 00763000306335: STENT GRAFT ESBF2814C103E ENDUR IIS BIF
• 00763000306328: STENT GRAFT ESBF2514C103E ENDUR IIS BIF
• 00763000306311: STENT GRAFT ESBF2314C103E ENDUR IIS BIF