SC-4108

GUDID 08714729821533

OR Cable 2x8 61cm and Extension

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729821533
• NIH Device Record Key: 341ef738-449b-4049-98b3-f4c7136c9366
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SC-4108
• Catalog Number: SC-4108
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	08714729821533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-24
• Device Publish Date: 2015-10-10

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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• 00191506018726 - Infinion™ Pro: 2024-04-30 Lead Kit 16 Contact 50cm
• 00191506018733 - Infinion™ Pro: 2024-04-30 Lead Kit 16 Contact 70cm
• 00191506020583 - mySCS™ GO: 2024-04-30 Therapy Controller
• 00191506020606 - mySCS™ GO: 2024-04-30 Therapy Controller
• 00191506020705 - mySCS™ GO: 2024-04-30 Therapy Controller App
• 08714729121688 - Precision ™: 2024-03-25 Adhesive Kit
• 08714729121435 - Precision™: 2024-03-19 Hex Wrench