GUDID 00643169449145

EXT 3708640 DBS NEW BOOT US SYM MRI

MEDTRONIC, INC.

Deep brain electrical stimulation system

• Primary Device ID: 00643169449145
• NIH Device Record Key: c904aca0-bcaf-4a5f-a3b1-594436e2eb38
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3708640
• Company DUNS: 796986144
• 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: false
• 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

Device Dimensions

• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169449145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960009

FDA Product Code

• MRU: implanted subcortical electrical Stimulator (motor disorders)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-18

Devices Manufactured by MEDTRONIC, INC.

• 20763000982946 - NA: 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
• 00763000984007 - NA: 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
• 00763000984021 - NA: 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
• 00763000984151 - NA: 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
• 00763000984168 - NA: 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
• 00763000984175 - NA: 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK
• 00763000180010 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693552 SPRINT US RCMCRD
• 00763000180027 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693575 SPRINT US RCMCRD