Sterile Revision Kit

GUDID 00818225020839

Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Sterile Revision Kit

STIMWAVE TECHNOLOGIES INCORPORATED

Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 00818225020839
• NIH Device Record Key: 57dd3cb6-ab9c-468c-a37b-64c7c6234642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Revision Kit
• Version Model Number: AF8A-ALL-1K
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818225020839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170141

FDA Product Code

• GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

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

[00818225020839]

Ethylene Oxide

[00818225020839]

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: 2018-02-05

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• 00818225021874 - PNS Wearable Accessory S/M: 2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
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• 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