Vercise™ M365DB9208150

GUDID 00191506014339

S8 Adapter 15cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system

• Primary Device ID: 00191506014339
• NIH Device Record Key: d2b9a7d0-411a-4fe0-8df9-d03a66f36902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise™
• Version Model Number: DB-9208-15
• Catalog Number: M365DB9208150
• 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: 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 Dimensions

• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506014339 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [Vercise™]

• 08714729992141: Neural Navigator 4 Installer
• 08714729989226: Charging System Kit
• 08714729976691: Neural Navigator 2.1 Installer
• 08714729965848: Charging System
• 08714729952145: ETS Adapter
• 08714729905295: M8 Adapter, 55cm
• 08714729905196: M8 Adapter, 15cm
• 08714729820871: Charging Collar Accessories
• 08714729820864: Charging Collar, Small
• 08714729820857: Charging Collar, Medium
• 08714729820796: Physicians Spare Kit
• 00191506014346: S8 Adapter 55cm
• 00191506014339: S8 Adapter 15cm