Freedom Spinal Cord Stimulator System FRE4-A000

GUDID 40859619004026

Freedom Spinal Cord Stimulator System Freedom-4 SCS Receiver Kit

STIMWAVE TECHNOLOGIES INCORPORATED

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 40859619004026
• NIH Device Record Key: ff23cd4e-3ef3-41ac-bdcd-45e578e94ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom Spinal Cord Stimulator System
• Version Model Number: FRE4-A000
• Catalog Number: FRE4-A000
• Company DUNS: 078294927
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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 Dimensions

• Length: 45 Centimeter
• Outer Diameter: 1.3 Millimeter
• Length: 45 Centimeter
• Outer Diameter: 1.3 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	40859619004026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141399

FDA Product Code

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

Sterilization

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

[40859619004026]

Ethylene Oxide

[40859619004026]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-11

On-Brand Devices [Freedom Spinal Cord Stimulator System]

• 00859619004936: Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel B US
• 00859619004929: Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel B US
• 00859619004912: Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel A US
• 00859619004882: Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel B US
• 00859619004875: Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel A US
• 00859619004103: Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel B US
• 00859619004097: Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel A US
• 00859619004042: Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel A US
• 00859619004035: Freedom Spinal Cord Stimulator System Longboard Wearable Antenna Assembly 915
• 00859619004028: Boogieboard Wearable Antenna Assembly 915
• 40859619004026: Freedom Spinal Cord Stimulator System Freedom-4 SCS Receiver Kit