InterStim™ SureScan™

GUDID 00763000203726

LEAD 978B128 ISTM SSMRI 4.32MM EMAN US

MEDTRONIC, INC.

Sacral plexus implantable incontinence-control electrical stimulation system electrode

• Primary Device ID: 00763000203726
• NIH Device Record Key: b43a0bd7-8d2b-4b23-a5f6-fb1b1c4957a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterStim™ SureScan™
• Version Model Number: 978B128
• 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: true
• 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

Device Dimensions

• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000203726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080025

FDA Product Code

• EZW: Stimulator, electrical, implantable, for incontinence

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: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [InterStim™ SureScan™]

• 00763000203801: LEAD 978B141 ISTM SSMRI 4.32MM EMAN US
• 00763000203764: LEAD 978B133 ISTM SSMRI 4.32MM EMAN US
• 00763000203726: LEAD 978B128 ISTM SSMRI 4.32MM EMAN US
• 00763000203689: LEAD 978A141 ISTM SSMRI 2.16MM EMAN US
• 00763000203641: LEAD 978A133 ISTM SSMRI 2.16MM EMAN US
• 00763000203603: LEAD 978A128 ISTM SSMRI 2.16MM EMAN US