Vercise™ Cartesia™ X M365DB2203300

GUDID 08714729966333

Directional Lead Kit, 16 Contact, 30cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729966333
• NIH Device Record Key: 7e56c2c0-b5a1-46af-bf13-52da29ea0eeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise™ Cartesia™ X
• Version Model Number: DB-2203-30
• Catalog Number: M365DB2203300
• 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 Dimensions

• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729966333 [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: 2024-12-23
• Device Publish Date: 2024-12-15

On-Brand Devices [Vercise™ Cartesia™ X]

• 08714729966340: Directional Lead Kit, 16 Contact, 45cm
• 08714729966333: Directional Lead Kit, 16 Contact, 30cm