InterStim™ Micro SureScan™

GUDID 00763000203849

INS 97810 ISTM MICRO SSMRI RC EMAN US

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system pulse generator

• Primary Device ID: 00763000203849
• NIH Device Record Key: 47fe6aea-3f17-475d-a299-d0df4720f998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterStim™ Micro SureScan™
• Version Model Number: 97810
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000203849 [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

Devices Manufactured by MEDTRONIC, INC.

• 00199150027521 - Cardioblate™: 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT
• 00199150027538 - Cardioblate™: 2026-01-26 CLAMP 49341 CARDIOBLATE LP FT
• 00199150027569 - Cardioblate™: 2026-01-26 CARDIOBLATE 60831 BP2 DEVICE EN
• 00199150027576 - Cardioblate®: 2026-01-26 CARDIOBLATE 60841 LP STANDALONE EN
• 00763000999414 - SYNCHROMED™ III: 2026-01-23 PUMP 8667-20 SYNCHROMEDIII EMAN
• 00763000999421 - SYNCHROMED™ III: 2026-01-23 PUMP 8667-40 SYNCHROMEDIII EMAN
• 10681490185162 - NA: 2026-01-21 POUCH 8590-1 SYNCHROMED PUMP US
• 00763000300623 - N/A: 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM