Vercise™ Cartesia™

GUDID 08714729905288

45cm 8 Contact DBS Directional Lead Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729905288
• NIH Device Record Key: e14b3e69-a379-4195-bdcb-bc554cba064b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vercise™ Cartesia™
• Version Model Number: DB-2202-45
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729905288 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-03
• Device Publish Date: 2019-01-20

On-Brand Devices [Vercise™ Cartesia™]

• 08714729905288: 45cm 8 Contact DBS Directional Lead Kit
• 08714729905271: 30cm 8 Contact DBS Directional Lead Kit