CycloTens Refill Pak

GUDID 20370914013019

One bottle 30 ct. Cyclobenzaprine 10 mg with one set of Tens Unit Electrode pads

HUDSON SCIENTIFIC, LLC

Transcutaneous electrical stimulation lead

• Primary Device ID: 20370914013019
• NIH Device Record Key: 40fa0a53-b6b9-4b55-ad90-6af881af4c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CycloTens Refill Pak
• Version Model Number: 50054A
• Company DUNS: 080339637
• Company Name: HUDSON SCIENTIFIC, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Customer Support Contacts

• Phone: 5172124047
• Email: angela.powell@hudsci.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370914013015 [Primary]
GS1	10370914013012 [Package]; Contains: 00370914013015; Package: Shipper Box [10 Units]; In Commercial Distribution
GS1	20370914013019 [Package]; Contains: 00370914013015; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133979

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-24

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• 20370914013019 - CycloTens Refill Pak: 2018-07-06One bottle 30 ct. Cyclobenzaprine 10 mg with one set of Tens Unit Electrode pads
• 20370914013019 - CycloTens Refill Pak: 2018-07-06 One bottle 30 ct. Cyclobenzaprine 10 mg with one set of Tens Unit Electrode pads
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