InterStim™ Micro SureScan™ MRI

GUDID 00763000596736

INS 97810 ISTM MICRO SSMRI RC EMAN US

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator Implantable incontinence-control electrical stimulation system pulse generator

• Primary Device ID: 00763000596736
• NIH Device Record Key: 72feed16-ff50-4cdb-8313-aba1bce3eb85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterStim™ Micro SureScan™ MRI
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000596736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080025

FDA Product Code

• QON: Implanted electrical device intended for treatment of fecal 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: 2022-06-13
• Device Publish Date: 2022-06-05

Devices Manufactured by MEDTRONIC, INC.

• 00763000944322 - NA: 2024-04-23 CUSTOM PACK HY4953R31 MEMB PK
• 00763000944339 - NA: 2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK
• 00763000944346 - NA: 2024-04-23 CUSTOM PACK BB12F35R5 A PACK
• 00763000945558 - NA: 2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO
• 00763000943844 - NA: 2024-04-12 CUSTOM PACK BB11J59R5 PEDS
• 00763000943851 - NA: 2024-04-12 CUSTOM PACK BB12F35R3 A PACK
• 00763000943868 - NA: 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
• 00763000943899 - NA: 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD