GUDID 00643169157385

LEAD 387360 OCTAD 1X8 BENT STYLT EMAN US

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169157385
• NIH Device Record Key: a35e384e-2119-4a6b-8f11-b5b302bb168b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 387360
• 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
• 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 Dimensions

• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169157385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051773

FDA Product Code

• GZB: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 2015-06-08

Devices Manufactured by MEDTRONIC, INC.

• 00199150021055 - NA: 2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT
• 00199150021062 - NA: 2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8
• 00199150021079 - NA: 2025-06-06 CUSTOM PACK BB7C59R10 E C L S
• 20199150021110 - NA: 2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E
• 20199150021134 - NA: 2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
• 00199150021147 - NA: 2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
• 20199150021165 - NA: 2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
• 20199150021653 - NA: 2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE