DynaGel™ Ultrasound Gel, 5 Liters, Clear 5LTRGEL

GUDID 20660584000915

Dynatronics Corporation

Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• Primary Device ID: 20660584000915
• NIH Device Record Key: 91bed515-703c-43d7-aa04-31656a8894a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaGel™ Ultrasound Gel, 5 Liters, Clear
• Version Model Number: 5LTRGEL
• Catalog Number: 5LTRGEL
• Company DUNS: 113399125
• Company Name: Dynatronics Corporation
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com

Device Dimensions

• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000918 [Primary]
GS1	20660584000915 [Package]; Contains: 10660584000918; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012522

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-11-18

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• 10660584000093 - Dynatron® ion™ Large: 2023-10-26
• 10660584000185 - Solaris Soundhead: 2023-10-26
• 10660584000192 - Solaris Soundhead: 2023-10-26