Inceptiv™

GUDID 00763000540302

INS 977119 INCEPTIV MRI US EMAN

MEDTRONIC, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 00763000540302
• NIH Device Record Key: dbe402fd-6f97-49a7-9db8-23ca9152d80d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inceptiv™
• Version Model Number: 977119
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000540302 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-13
• Device Publish Date: 2024-05-05

Devices Manufactured by MEDTRONIC, INC.

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• 00763000228699 - NA: 2024-07-08 KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ
• 00763000957193 - NA: 2024-07-08 CUSTOM PACK BB7M46R25 SCV ADLT
• 20763000960272 - NA: 2024-07-08 CUSTOM PACK 10R91R5 10PK LRTXBYPS
• 20763000960296 - NA: 2024-07-08 CUSTOM PACK SSBB12D06R4 4PK RESOXY BYPA
• 00763000879273 - Verify™: 2024-07-05 ENS 353101 VERIFY ISTM US EMANUAL
• 00763000879280 - Verify™: 2024-07-05 ENS 353101 VERIFY ISTM US REFURB EMAN