ActaStim-S 1101-0002

GUDID 00850372007172

ActaStim-S Spine Fusion Stimulator Battery

THERAGEN, LLC

Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 00850372007172
• NIH Device Record Key: 3a6eaeef-1491-48cd-afce-715a7652fb01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActaStim-S
• Version Model Number: 1101-0002
• Catalog Number: 1101-0002
• Company DUNS: 080028759
• Company Name: THERAGEN, LLC
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com
• Phone: 1-800-901-5667
• Email: help@actastim.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850372007172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190030

FDA Product Code

• LOF: Stimulator, Bone Growth, Non-Invasive

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: 2021-02-16
• Device Publish Date: 2021-02-08

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• 00850372007226: ActStim-S Spine Fusion Stimulator Charger
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• 00850372007202: ActaStim-S Spine Fusion Stimulator - Electrodes, Type 1
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• 00850372007189: ActaStim-S Spine Fusion Stimulator - Leadwire, Long
• 00850372007172: ActaStim-S Spine Fusion Stimulator Battery
• 00850372007165: ActaStim-S Spine Fusion Stimulator Generator