Verify® External Neurostimulator

GUDID 00763000344573

ENS 353101 VERIFY ISTM US EMANUAL

MEDTRONIC, INC.

Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator

• Primary Device ID: 00763000344573
• NIH Device Record Key: 6beed998-6ff7-48ac-ab2b-6cc97c9e57c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verify® External Neurostimulator
• 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
• 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	00763000344573 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

Devices Manufactured by MEDTRONIC, INC.

• 00199150005628 - NA: 2025-04-14 CUSTOM PACK BB12H36R7 PUMP TABLE
• 00199150005864 - NA: 2025-04-14 CUSTOM PACK BB11P84R2 FEM-AX
• 00199150005871 - NA: 2025-04-14 CUSTOM PACK BB10H16R9 PEDI
• 20199150005899 - NA: 2025-04-14 CUSTOM PACK BB4M03R3 2PK 3/8 VEN
• 00199150005901 - NA: 2025-04-14 CUSTOM PACK BB1W12R37 CV
• 20199150005943 - NA: 2025-04-14 CUSTOM PACK BB10N58R1 5PK HRTASSTPIGTAI
• 20199150005967 - NA: 2025-04-14 CUSTOM PACK BB6J29R1 5PK 3/8 VENOU
• 20199150006001 - NA: 2025-04-14 CUSTOM PACK 12N80R 5PK 1/4 SILASTIC TUB