RestorePRIME™

GUDID 00613994842299

INS 37701 RESTR PRIME BLUE TORQ WRNCH US

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00613994842299
• NIH Device Record Key: 018127cd-c3d0-40c2-ab0b-ebd78f93ef50
• Commercial Distribution Discontinuation: 2016-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RestorePRIME™
• Version Model Number: 37701
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994842299 [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.

• 00199150001811 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU04020013P D4.0 L200 UL0130
• 00199150001828 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU04020020P D4.0 L200 UL0200
• 00199150001842 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU04025013P D4.0 L250 UL0130
• 00199150001859 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU04025020P D4.0 L250 UL0200
• 00199150001873 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU05020013P D5.0 L200 UL0130
• 00199150001880 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU05020020P D5.0 L200 UL0200
• 00199150001903 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU05025013P D5.0 L250 UL0130
• 00199150001910 - IN.PACT™ 018: 2026-03-27 DCB 018XL IPU05025020P D5.0 L250 UL0200