Amplatzer™ Amulet™ 9-ACP2-007-016

GUDID 00811806013459

Left Atrial Appendage Occluder

ST. JUDE MEDICAL, INC.

Cardiac occluder

• Primary Device ID: 00811806013459
• NIH Device Record Key: 7ada2127-ca5e-4d5b-b8d8-994e84598c62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplatzer™ Amulet™
• Version Model Number: 9-ACP2-007-016
• Catalog Number: 9-ACP2-007-016
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, 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: 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811806013459 [Primary]

FDA Product Code

• NGV: System, appendage closure, left atrial

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: 2021-08-24
• Device Publish Date: 2021-08-16

On-Brand Devices [Amplatzer™ Amulet™]

• 00811806013527: Left Atrial Appendage Occluder
• 00811806013510: Left Atrial Appendage Occluder
• 00811806013503: Left Atrial Appendage Occluder
• 00811806013497: Left Atrial Appendage Occluder
• 00811806013480: Left Atrial Appendage Occluder
• 00811806013473: Left Atrial Appendage Occluder
• 00811806013466: Left Atrial Appendage Occluder
• 00811806013459: Left Atrial Appendage Occluder