InterStim™

GUDID 00763000203887

EXT 3560030 ISTM QUAD PERC 2.16MM

MEDTRONIC, INC.

Sacral plexus percutaneous incontinence-control electrical stimulation system electrode

• Primary Device ID: 00763000203887
• NIH Device Record Key: 2934dcd0-9f18-4f97-b94d-9a386df3d366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterStim™
• Version Model Number: 3560030
• 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: 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: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000203887 [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™]

• 00763000114060: NEEDLE 041839 FORAMN 5IN 20GA GLBL 2PK
• 00763000114053: NEEDLE 041838 FORAMN 3.5IN 20GA GLBL 6PK
• 00763000114114: LEAD 309201 ISTIM TEST STIM EMAN LF45
• 00763000114077: LEAD 306001 ISTM PNE TST STM 1PK EMAN
• 00763000114169: CABLE 357506 MINI HOOK 6PK GLOBAL
• 00763000114152: CABLE 357501 MINI HOOK 1PK GLOBAL
• 00763000203900: ACCY 3560031 ISTM REVISION KIT
• 00763000203894: EXT 3560022 ISTM QUAD PERC 4.32MM
• 00763000203887: EXT 3560030 ISTM QUAD PERC 2.16MM
• 00763000343323: CABLE 367675 ISTM UNIPLR PAT 3W GLBL MDR
• 00763000343316: CABLE 357975 ISTM UNIPLR PAT 2W GLBL MDR
• 00763000343279: ACCY 041826 INTRSTIM GROUND PAD GLBL MDR
• 00763000295547: LEAD 309201 ISTIM TEST STIM EMAN LF45
• 00763000295523: LEAD 306001 ISTIM PNE TEST STIM US