Vercise ™ M365DB7105N5010

GUDID 00191506047733

Neural Navigator 5 Version 5.0.1

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 00191506047733
• NIH Device Record Key: 7fcb9218-70d1-4150-86b2-32110290d5da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise ™
• Version Model Number: DB-7105-N501
• Catalog Number: M365DB7105N5010
• 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	00191506047733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

• MHY: Stimulator, electrical, implanted, for parkinsonian tremor

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: 2024-06-24
• Device Publish Date: 2024-06-14

On-Brand Devices [Vercise ™]

• 08714729992158: Neural Navigator 3.1 Installer
• 08714729994909: Neural Navigator 3.1 Installer
• 08714729989233: External Trial Stimulator
• 00191506023218: Neural Navigator 5
• 00191506047733: Neural Navigator 5 Version 5.0.1