TALENT® OCCLUDER

GUDID 00763000233785

STENT GRAFT OCL22US 22MM OCCLUDER

MEDTRONIC, INC.

Abdominal aorta endovascular stent-graft

• Primary Device ID: 00763000233785
• NIH Device Record Key: 03743ee4-9e54-4080-914d-0d449793f96e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TALENT® OCCLUDER
• Version Model Number: OCL22US
• 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

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000233785 [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: 2019-07-26
• Device Publish Date: 2019-07-18

On-Brand Devices [TALENT® OCCLUDER]

• 00613994573186: STENT GRAFT OCL08US 8MM OCCLUDER
• 00613994573162: STENT GRAFT OCL10US 10MM OCCLUDER
• 00613994573148: STENT GRAFT OCL12US 12MM OCCLUDER
• 00613994573124: STENT GRAFT OCL14US 14MM OCCLUDER
• 00613994573100: STENT GRAFT OCL16US 16MM OCCLUDER
• 00613994573087: STENT GRAFT OCL18US 18MM OCCLUDER
• 00613994573063: STENT GRAFT OCL20US 20MM OCCLUDER
• 00613994573049: STENT GRAFT OCL22US 22MM OCCLUDER
• 00613994573025: STENT GRAFT OCL24US 24MM OCCLUDER
• 00763000233792: STENT GRAFT OCL24US 24MM OCCLUDER
• 00763000233785: STENT GRAFT OCL22US 22MM OCCLUDER
• 00763000233778: STENT GRAFT OCL20US 20MM OCCLUDER
• 00763000233761: STENT GRAFT OCL18US 18MM OCCLUDER
• 00763000233754: STENT GRAFT OCL16US 16MM OCCLUDER
• 00763000233747: STENT GRAFT OCL14US 14MM OCCLUDER
• 00763000233730: STENT GRAFT OCL12US 12MM OCCLUDER
• 00763000233723: STENT GRAFT OCL10US 10MM OCCLUDER
• 00763000233716: STENT GRAFT OCL08US 8MM OCCLUDER