Spectra WaveWriter™

GUDID 08714729951254

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 08714729951254
• NIH Device Record Key: e80817bb-d75c-4806-827e-9536a11b67e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra WaveWriter™
• Version Model Number: SC-1160
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729951254 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-09-30
• Device Publish Date: 2017-06-05

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