Vercise™ Cartesia™ HX M365DB2204450

GUDID 08714729966364

Directional Lead Kit, 16 Contact, 45cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729966364
• NIH Device Record Key: f8ec7a08-3ab0-4a67-b8a5-19deefe12939
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise™ Cartesia™ HX
• Version Model Number: DB-2204-45
• Catalog Number: M365DB2204450
• 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: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729966364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150031

FDA Product Code

• MHY: Stimulator, electrical, implanted, for parkinsonian 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™ HX]

• 08714729966364: Directional Lead Kit, 16 Contact, 45cm
• 08714729966357: Directional Lead Kit, 16 Contact, 30cm