GUDID 00643169887732

EXTN 3708120 OCTAD 1X8 20CM US FWU

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169887732
• NIH Device Record Key: b969a9f2-4377-4ea4-a1ea-a75ad4d0698c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3708120
• 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	00643169887732 [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

Devices Manufactured by MEDTRONIC, INC.

• 00763000974572 - NA: 2024-09-10 CUSTOM PACK BB3X42R20 UNV
• 20763000181080 - NA: 2024-09-09 CABLE 5833SL SURGICAL5PK DISP
• 20763000181110 - NA: 2024-09-09 CABLE 5846AL ROHS GLB 5PK
• 20763000181134 - NA: 2024-09-09 CABLE 5846VL ROHS GLB 5PK
• 20763000181165 - NA: 2024-09-09 CABLE 5487L DISP STER ROHS 5PK
• 20763000971469 - NA: 2024-09-09 CUSTOM PACK SS12H78R 10PK PEG TABLE 2.0
• 00763000974169 - NA: 2024-09-09 CUSTOM PACK BB12H50R1 SVI SUPPORT
• 00763000974176 - NA: 2024-09-09 CUSTOM PACK PDBB12H02R3 PED SUPP PK