RestoreAdvanced®SureScan®

GUDID 00643169553132

INS 97713 RSTORADVN SS MRI EMAN COQUIPUL

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169553132
• NIH Device Record Key: 4f186105-40f1-405b-9172-308e988e879c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RestoreAdvanced®SureScan®
• Version Model Number: 97713
• 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

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169553132 [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: 2016-05-08

Devices Manufactured by MEDTRONIC, INC.

• 00199150031610 - NA: 2025-07-21 CUSTOM PACK BB1U06R24 CHRIS AD
• 00199150032464 - NA: 2025-07-21 CUSTOM PACK BB10R35R4 CP PRIME
• 20199150032482 - NA: 2025-07-21 CUSTOM PACK 6S19R4 10PK DIALYSIS
• 00199150033423 - NA: 2025-07-21 CUSTOM PACK BB12B90R7 SPECTRU
• 20199150033571 - NA: 2025-07-21 CUSTOM PACK BB2U59R3 2PK 1/4 TBL L
• 00199150033614 - NA: 2025-07-21 CUSTOM PACK BB10J74R14 3/8CNTRIS
• 00199150034246 - NA: 2025-07-21 CUSTOM PACK BB11J86R12 ADULT E
• 00763000925093 - FlexCath Cross™ Transseptal Solution: 2025-07-21 NDL 900302 FLEXCATH CROSS SL 63CM EIFU