GUDID 00643169887756

EXTN 3708160 OCTAD 1X8 60CM US FWU

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension

• Primary Device ID: 00643169887756
• NIH Device Record Key: a052a059-57cb-4bb5-a9a4-22dc9399b303
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3708160
• 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
• 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
• 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
• 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
• 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
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169887756 [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: 2017-07-15

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