Large Antenna 30" Length

GUDID 00818225020563

Large Antenna 30" Length

STIMWAVE TECHNOLOGIES INCORPORATED

Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer

• Primary Device ID: 00818225020563
• NIH Device Record Key: 2a1bd149-2ae5-48ef-906f-7e15ba7f252f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Antenna 30" Length
• Version Model Number: MD0701-30-SS
• Company DUNS: 078294927
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 Dimensions

• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch
• Length: 76.2 Centimeter
• Length: 30 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818225020563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180981

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: 2018-11-26
• Device Publish Date: 2018-10-25

Devices Manufactured by STIMWAVE TECHNOLOGIES INCORPORATED

• 00850051034222 - SandShark Injectable Anchor System: 2023-04-07 SandShark Injectable Anchor System
• 00818225021850 - PNS Wearable Accessory L/XL Vertical: 2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
• 00818225021867 - PNS Wearable Accessory L/XL Horizontal: 2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
• 00818225021874 - PNS Wearable Accessory S/M: 2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
• 00818225022031 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size XS Assembly
• 00818225022048 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size S Assembly
• 00818225022055 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size M Assembly
• 00818225022062 - Stimwave Freedom Spinal Cord Stimulation System: 2023-02-22 Torso Belt Size L Assembly