Specify® SureScan®

GUDID 00763000324216

LEAD 977C190 SPECIFY SRSCN 565 SRG EMAN

MEDTRONIC, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

• Primary Device ID: 00763000324216
• NIH Device Record Key: af7f8511-f5ba-4f13-805a-082a70fa1398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Specify® SureScan®
• Version Model Number: 977C190
• 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

Device Dimensions

• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000324216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

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: 2022-03-07
• Device Publish Date: 2022-02-26

On-Brand Devices [Specify® SureScan®]

• 00763000324230: LEAD 977C290 SPECIFY SURESCAN 2X8 SRG
• 00763000324223: LEAD 977C265 SPECIFY SURESCAN 2X8 SRG
• 00763000324216: LEAD 977C190 SPECIFY SRSCN 565 SRG EMAN
• 00763000324209: LEAD 977C165 SPECIFY SRSCN 565 SRG EMAN