PrimeAdvanced® SureScan®

GUDID 00643169109513

INS 97702 RESTORE PRIME ADVANCED MRICS

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169109513
• NIH Device Record Key: d9c16bc3-1ac3-4483-b136-2d5870d9753b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimeAdvanced® SureScan®
• Version Model Number: 97702
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169109513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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: 2018-07-06
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

• 00199150068180 - NA: 2026-02-02 CUSTOM PACK BB12H59R3 HLN UCHICAGCP
• 00199150068210 - NA: 2026-02-02 CUSTOM PACK BB8Y34R13 LOWVOLPED
• 20199150068238 - NA: 2026-02-02 CUSTOM PACK BB12S73R1 20PK ACC 3LF
• 20199150068290 - NA: 2026-02-02 CUSTOM PACK 12T24R 5PK ACC CARDIO
• 20199150068405 - NA: 2026-02-02 CUSTOM PACK BB12R56R3 4PK CPN DEL NI
• 00199150061679 - NA: 2026-01-29 CUSTOM PACK BB12S73R HLN 3LF
• 20613994654063 - DLP®: 2026-01-29 PCP SET 50011 5FR - 14GA 10PK 17L
• 00199150027521 - Cardioblate™: 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT