Vercise Genus™

GUDID 08714729985020

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729985020
• NIH Device Record Key: f53dab7c-eb42-4ac3-9647-be7e08b517d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise Genus™
• Version Model Number: DB-1416
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION 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: false
• 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	08714729985020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

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

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: 2021-02-05
• Device Publish Date: 2021-01-28

On-Brand Devices [Vercise Genus™]

• 08714729989752: Implantable Pulse Generator Kit
• 08714729985044: Implantable Pulse Generator Kit
• 08714729985020: Implantable Pulse Generator Kit
• 08714729985051: Implantable Pulse Generator Kit
• 08714729985037: Implantable Pulse Generator Kit