mySCS™ GO

GUDID 00191506020705

Therapy Controller App

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable spinal cord electrical stimulation system programmer

• Primary Device ID: 00191506020705
• NIH Device Record Key: 9b3b3590-5939-486b-94d5-bc8abe7b081b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mySCS™ GO
• Version Model Number: SC-5275
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506020705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [mySCS™ GO]

• 00191506020705: Therapy Controller App
• 00191506020606: Therapy Controller
• 00191506020583: Therapy Controller