Sprint Quattro™ MRI SureScan™

GUDID 00643169858305

LEAD 6946M55 MRI USA SPRINT DF4

MEDTRONIC, INC.

Endocardial defibrillation lead

• Primary Device ID: 00643169858305
• NIH Device Record Key: d0617e47-16b0-4f81-bd4e-99392330f08c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sprint Quattro™ MRI SureScan™
• Version Model Number: 6946M55
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: true
• Single Use: true
• 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
• 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

• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169858305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P920015

FDA Product Code

• NVY: Permanent defibrillator electrodes

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: 2018-08-13
• Device Publish Date: 2017-06-11

On-Brand Devices [Sprint Quattro™ MRI SureScan™]

• 00643169858329: LEAD 6946M62 MRI USA SPRINT DF4
• 00643169858305: LEAD 6946M55 MRI USA SPRINT DF4