ClosureRFG™

GUDID 10884521777545

GENERATOR RFG3 CLOSUREFAST

MEDTRONIC, INC.

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 10884521777545
• NIH Device Record Key: cad5e9c1-df29-4033-9036-3477f42faa16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClosureRFG™
• Version Model Number: RFG3
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 hPa
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521777545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141858

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2019-08-10

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