Verify®

GUDID 00763000640491

ENS 353101 VERIFY ISTM US REFURB EMAN

MEDTRONIC, INC.

Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator

• Primary Device ID: 00763000640491
• NIH Device Record Key: f28e23c0-246a-49ad-8b7f-646ceb001aae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verify®
• Version Model Number: 353101
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000640491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970004

FDA Product Code

• EZW: Stimulator, electrical, implantable, for incontinence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-05
• Device Publish Date: 2022-06-27

On-Brand Devices [Verify®]

• 00643169968783: ENS 353101 INTERSTIM TEST STIMULATOR
• 00763000640491: ENS 353101 VERIFY ISTM US REFURB EMAN