GUDID 08714729820772

30cm Lead Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729820772
• NIH Device Record Key: 5b661f79-a77f-44f3-8f78-389b07eb17bc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DB-2201-30AC
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729820772 [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: 5
• Public Version Date: 2021-10-29
• Device Publish Date: 2017-12-15

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 00191506048464 - GX1™: 2025-10-07 Radiofrequency Generator 2.0A, 120V
• 00191506048518 - GX1™: 2025-10-07 Radiofrequency Generator 2.0A, 220V
• 00191506048563 - GX1™: 2025-10-07 Radiofrequency Generator 2.0A, 240V
• 00191506059309 - GX1™: 2025-10-07 Radiofrequency Generator
• 00191506059330 - GX1™: 2025-10-07 GX1 RF GENERATOR HW 120V
• 00191506059347 - GX1™: 2025-10-07 GX1 RF GENERATOR HW 220V
• 00191506059354 - GX1™: 2025-10-07 GX1 RF GENERATOR HW 240V
• 08714729951254 - Spectra WaveWriter™: 2025-09-30 Implantable Pulse Generator Kit