PISCES-QUAD™

GUDID 00613994722171

LEAD 3487A-45 PISCES QUAD 9MM SP US EMAN

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead

• Primary Device ID: 00613994722171
• NIH Device Record Key: a417ed02-a663-4e06-aec6-cd407b45ac17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PISCES-QUAD™
• Version Model Number: 3487A-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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994722171 [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 [PISCES-QUAD™]

• 00613994722188: LEAD 3487A-33 PISCES QUAD 9MM SP US EMAN
• 00613994722171: LEAD 3487A-45 PISCES QUAD 9MM SP US EMAN