RestoreUltra® SureScan®

GUDID 00643169109506

INS 97712 RESTORE ULTRA MRICS

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169109506
• NIH Device Record Key: dd358a9b-a78b-4949-950f-9dcac2e8899e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RestoreUltra® SureScan®
• Version Model Number: 97712
• 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 -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169109506 [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.

• 00763000613617 - Mosaic™7308C: 2025-03-11 SIZERS 7308C MOSAIC CINCH AORTIC MDR
• 00763000613624 - Mosaic Ultra™7308U: 2025-03-11 SIZERS 7308U MOSAIC ULTRA AORTIC MDR
• 00763000613631 - Mosaic™7310: 2025-03-11 OBTURATORS 7310 MOSAIC MITRAL MDR
• 00763000613648 - NA: 2025-03-11 HANDLE 7639 VALVE MDR
• 00763000613655 - NA: 2025-03-11 HANDLE 7639XL VALVE XL MDR
• 00763000613662 - NA: 2025-03-11 ACCESSORY 7642 LOCK NUT MDR
• 00763000614034 - Hancock™ II 7505: 2025-03-11 OBTURATOR 7505SET HK II AORTIC MDR
• 00763000614041 - Hancock™ II 7510: 2025-03-11 OBTURATOR 7510SET HK II MITRAL MDR