SetPoint Implant

GUDID 00860013950200

SetPoint Medical Corporation

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

• Primary Device ID: 00860013950200
• NIH Device Record Key: c5a23fd9-9d04-4e67-9df2-59886fc62bb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SetPoint Implant
• Version Model Number: M01
• Company DUNS: 957136315
• Company Name: SetPoint Medical Corporation
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013950200 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-14
• Device Publish Date: 2025-08-06

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
• 00860013950200 - SetPoint Implant: 2025-08-14
• 00860013950200 - SetPoint Implant: 2025-08-14