Spectra WaveWriter™

GUDID 08714729978404

External Trial Stimulator (Refurbished)

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

• Primary Device ID: 08714729978404
• NIH Device Record Key: 398ff16d-7e76-4f60-9cd0-6bad53e7eaca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra WaveWriter™
• Version Model Number: SC-5160R
• 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: true
• 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	08714729978404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-09-30
• Device Publish Date: 2018-05-11

On-Brand Devices [Spectra WaveWriter™]

• 08714729978404: External Trial Stimulator (Refurbished)
• 08714729953432: Implantable Pulse Generator and Charging Kit
• 08714729952046: External Trial Stimulator
• 08714729951254: Implantable Pulse Generator Kit