Itrel® 4

GUDID 00643169107793

INS 37703 ITREL 4 NEUROSTIMULATOR

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169107793
• NIH Device Record Key: c8db90e7-9ba3-4cbd-b36f-ef06f50c8cb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Itrel® 4
• Version Model Number: 37703
• 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	00643169107793 [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

On-Brand Devices [Itrel® 4]

• 00643169107809: INS 37704 ITREL 4X NEUROSTIMULATOR
• 00643169107793: INS 37703 ITREL 4 NEUROSTIMULATOR