Stimwave Freedom Spinal Cord Stimulation System

GUDID 00818225022079

Torso Belt Size XL Assembly

STIMWAVE TECHNOLOGIES INCORPORATED

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• Primary Device ID: 00818225022079
• NIH Device Record Key: 315d3c65-861d-446c-b07d-50e31c122363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stimwave Freedom Spinal Cord Stimulation System
• Version Model Number: 00-52016
• Company DUNS: 078294927
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• 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	00818225022079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182720

FDA Product Code

• GZB: Stimulator, Spinal-Cord, Implanted (Pain Relief)

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: 2023-02-22
• Device Publish Date: 2023-02-14

On-Brand Devices [Stimwave Freedom Spinal Cord Stimulation System]

• 00818225022086: Torso Belt Size XXL Assembly
• 00818225022079: Torso Belt Size XL Assembly
• 00818225022062: Torso Belt Size L Assembly
• 00818225022055: Torso Belt Size M Assembly
• 00818225022048: Torso Belt Size S Assembly
• 00818225022031: Torso Belt Size XS Assembly