PISCES-QUAD PLUS ™

GUDID 00643169887909

LEAD 3888-45 PSCES4+ 45CM BLUTRQ EMN FWU

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169887909
• NIH Device Record Key: 8a6640cd-40dd-46d2-b8bd-d735ec35e7d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PISCES-QUAD PLUS ™
• Version Model Number: 3888-45
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169887909 [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: 2017-07-16

On-Brand Devices [PISCES-QUAD PLUS ™]

• 00643169887916: LEAD 3888-56 PSCES4+ 56CM BLUTRQ EMN FWU
• 00643169887909: LEAD 3888-45 PSCES4+ 45CM BLUTRQ EMN FWU
• 00643169887893: LEAD 3888-33 PSCES4+ 33CM BLUTRQ EMN FWU
• 00643169887886: LEAD 3888-56 PISCES4+ 56CM BLU TRQ FWU
• 00643169887879: LEAD 3888-45 PISCES4+ 45CM BLU TRQ FWU
• 00643169887862: LEAD 3888-33 PISCES4+ 33CM BLU TRQ FWU