M365DB3216550

GUDID 08714729966395

16 Contact Lead Extension Kit, 55 cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729966395
• NIH Device Record Key: f811742a-c89a-4805-820b-1716ee0f5eae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DB-3216-55
• Catalog Number: M365DB3216550
• 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: 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	08714729966395 [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: 2024-12-23
• Device Publish Date: 2024-12-15

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 00191506047276 - Vercise ™ DBS: 2025-03-04 Controller
• 00191506047283 - Vercise ™ DBS: 2025-03-04 Controller Patient Kit
• 00191506047290 - Vercise ™ DBS: 2025-03-04 Controller Clinician Kit
• 08714729966333 - Vercise™ Cartesia™ X: 2024-12-23 Directional Lead Kit, 16 Contact, 30cm
• 08714729966340 - Vercise™ Cartesia™ X: 2024-12-23 Directional Lead Kit, 16 Contact, 45cm
• 08714729966357 - Vercise™ Cartesia™ HX: 2024-12-23 Directional Lead Kit, 16 Contact, 30cm
• 08714729966364 - Vercise™ Cartesia™ HX: 2024-12-23 Directional Lead Kit, 16 Contact, 45cm
• 08714729966371 - NA: 2024-12-23 Lead Extension Kit, 2x8 Contact, 55cm