GUDID 00643169157361

LEAD 387345 OCTAD 1X8 BNT STYLET EMAN US

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00643169157361
• NIH Device Record Key: 4b53b61c-9a7d-4814-bbe7-2231487d094c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 387345
• 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: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169157361 [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

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