Symplicity Spyral™

GUDID 00763000354466

SPYRAL CATHETER RDN016 US COMMERCIAL

MEDTRONIC, INC.

Renal denervation radio-frequency ablation catheter

• Primary Device ID: 00763000354466
• NIH Device Record Key: 002038bf-d386-4268-85de-9e6ce3a12fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symplicity Spyral™
• Version Model Number: RDN016
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar
• Storage Environment Temperature: Between -35 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
• Storage Environment Atmospheric Pressure: Between 595 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000354466 [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: true

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

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