Amplatzer™ TorqVue™ 45° x 45° 9-TV45X45-12F-080

GUDID 05415067025883

Delivery Sheath

AGA MEDICAL CORPORATION

Cardiac occluder delivery kit

• Primary Device ID: 05415067025883
• NIH Device Record Key: d5752b96-d1c6-4adc-bd3f-6d0e2912f26c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplatzer™ TorqVue™ 45° x 45°
• Version Model Number: Delivery Sheath
• Catalog Number: 9-TV45X45-12F-080
• Company DUNS: 966215829
• Company Name: AGA MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Dimensions

• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter
• Catheter Gauge: 12 French
• Length: 80 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067025883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163000

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

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: 2017-02-25

On-Brand Devices [Amplatzer™ TorqVue™ 45° x 45°]

• 05415067025906: Delivery Sheath
• 05415067025883: Delivery Sheath