Vercise ™ DBS M365DB52900

GUDID 00191506047290

Controller Clinician Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 00191506047290
• NIH Device Record Key: fd4ba57b-c80e-472c-b9ff-581d1f8b3622
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise ™ DBS
• Version Model Number: DB-5290
• Catalog Number: M365DB52900
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506047290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

• NHL: Stimulator, electrical, implanted, for parkinsonian symptoms

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: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [Vercise ™ DBS]

• 00191506047290: Controller Clinician Kit
• 00191506047283: Controller Patient Kit
• 00191506047276: Controller