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

• 08714729950684 - Entrada ™: 2025-08-25 Needle 11cm (4.5in)
• 08714729950691 - Entrada ™: 2025-08-25 Needle 15cm (6.0 in)
• 08714729950707 - Entrada ™: 2025-08-25 Spare Sheath 11cm (4.5 in)
• 08714729950714 - Entrada ™: 2025-08-25 Spare Sheath 15cm (6.0 in)
• 08714729952053 - Freelink™: 2025-08-25 Remote Control
• 08714729953449 - Freelink™: 2025-08-25 Remote Control Kit
• 08714729953487 - Bionic Navigator™ 3D: 2025-08-25 BN 3D 2.0 Installer
• 08714729820758 - Vercise™: 2025-08-12 Implantable Pulse Generator Kit