SetPoint Programmer

GUDID 00860013950248

SetPoint Medical Corporation

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

• Primary Device ID: 00860013950248
• NIH Device Record Key: 35cc22c0-8c08-4878-a009-b9e647b23734
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SetPoint Programmer
• Version Model Number: v2
• Company DUNS: 957136315
• Company Name: SetPoint Medical Corporation
• 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: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013950248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240039

FDA Product Code

• SFJ: Vagus Nerve Stimulator For Rheumatoid Arthritis

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: 2025-08-20
• Device Publish Date: 2025-08-12

Devices Manufactured by SetPoint Medical Corporation

• 00860013950217 - SetPoint Charger and Docking Station: 2025-08-20
• 00860013950224 - SetPoint Charger: 2025-08-20
• 00860013950231 - SetPoint Docking Station: 2025-08-20
• 00860013950248 - SetPoint Programmer: 2025-08-20
• 00860013950248 - SetPoint Programmer: 2025-08-20
• 00860013950200 - SetPoint Implant: 2025-08-14