Vercise™ DBS

GUDID 08714729989196

Remote Control Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729989196
• NIH Device Record Key: a1ecb9e9-3e6b-434a-9c2f-90c6de42e529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise™ DBS
• Version Model Number: DB-5572-1
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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	08714729989196 [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: false

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™ DBS]

• 08714729989202: Remote Control
• 08714729989196: Remote Control Kit
• 08714729984474: External Trial Stimulator 2
• 08714729984436: Remote Control 3
• 08714729965831: Remote Control 3 Kit