Symplicity G3™

GUDID 00763000387020

GENERATOR RDNG3A G3SV5.1 US JP CA

MEDTRONIC, INC.

Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 00763000387020
• NIH Device Record Key: 72f1e5f2-9e8c-417d-835c-c51550711ea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symplicity G3™
• Version Model Number: RDNG3A
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000387020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220026

FDA Product Code

• QYI: Ablation catheter, renal denervation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-08
• Device Publish Date: 2023-11-30

On-Brand Devices [Symplicity G3™]

• 00643169615984: SYMPLICITY RDN019 G3 CART GLOBAL
• 00763000387037: CART RDN019 SYMPLICITY G3 GLOBAL
• 00763000387020: GENERATOR RDNG3A G3SV5.1 US JP CA