Vercise ™ DB-5170

GUDID 08714729989233

External Trial Stimulator

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729989233
• NIH Device Record Key: 4cea68bc-e37e-44b6-9bad-5eff98b3aefa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise ™
• Version Model Number: DB-5170
• Catalog Number: DB-5170
• 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	08714729989233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

• NHL: Stimulator, electrical, implanted, for parkinsonian symptoms
• PJS: Stimulator, electrical, implanted, for essential 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: 2021-02-05
• Device Publish Date: 2021-01-28

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