RestoreUltra® SureScan®

GUDID 00643169109506

INS 97712 RESTORE ULTRA MRICS

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system 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.

• 00763000943844 - NA: 2024-04-12 CUSTOM PACK BB11J59R5 PEDS
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• 00763000943899 - NA: 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD
• 00763000943882 - NA: 2024-04-12 CUSTOM PACK BB12C41R4 10PK LUNG PACK
• 00763000825539 - NA: 2024-04-08 REV KIT 8598A SPNL SGMNT CATH EMAN
• 00763000893491 - SHERPA NX BALANCED™: 2024-04-08 CATHETER SB6CHAMP05SH SB 6F 100CM CH05
• 20763000933412 - NA: 2024-04-08 CUSTOM PACK 12F60R 10PK VENTED SPIKE