PISCES-Quad®

GUDID 00643169516618

LEAD 3487A-33 PISCES QD NO SCRN CBL EMAN

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169516618
• NIH Device Record Key: 186c2458-e2d0-4b42-92d7-5f3d1bef239b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PISCES-Quad®
• Version Model Number: 3487A-33
• 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: 33 Centimeter
• Length: 33 Centimeter
• Length: 33 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169516618 [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: 2015-02-11

On-Brand Devices [PISCES-Quad®]

• 00613994951779: LEAD 3487A-33 PISCES QUAD BLU TRQ PAPER
• 00613994951762: LEAD 3487A-45 PISCES QUAD BLU TRQ PAPER
• 00613994951755: LEAD 3487A-56 PISCES QUAD BLU TRQ PAPER
• 00643169887725: LEAD 3487A-56 PISCES QUAD US FWU
• 00643169887718: LEAD 3487A-56 PISCES QUAD US EMAN FWU
• 00643169887701: LEAD 3487A-45 PISCES QUAD US FWU
• 00643169887695: LEAD 3487A-45 PISCES QUAD US EMAN FWU
• 00643169887688: LEAD 3487A-33 PISCES QUAD US FWU
• 00643169887671: LEAD 3487A-33 PISCES QUAD US EMAN FWU
• 00643169516731: LEAD 3888-56 PISCES QD EMAN NO SCRN CBL
• 00643169516724: LEAD 3888-45 PISCES QD EMAN NO SCRN CBL
• 00643169516717: LEAD 3888-33 PISCES QD EMAN NO SCRN CBL
• 00643169516687: LEAD 3887-56 PISCES QD EMAN NO SCRN CBL
• 00643169516670: LEAD 3887-45 PISCES QD EMAN NO SCRN CBL
• 00643169516663: LEAD 3887-33 PISCES QD BLU TRQ EMAN SCS
• 00643169516632: LEAD 3487A-56 PISCES QD NO SCRN CBL EMAN
• 00643169516625: LEAD 3487A-45 PISCES QD NO SCRN CBL EMAN
• 00643169516618: LEAD 3487A-33 PISCES QD NO SCRN CBL EMAN