Vercise™ M365DB9208550

GUDID 00191506014346

S8 Adapter 55cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 00191506014346
• NIH Device Record Key: 4b123f40-25eb-4064-8cd4-67e04fe2917c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise™
• Version Model Number: DB-9208-55
• Catalog Number: M365DB9208550
• 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: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter
• Length: 55 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506014346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

• PJS: Stimulator, electrical, implanted, for essential tremor

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
• 08714729989240: Physicians Spare Kit, 16 Contact Lead