DynaGel™ Ultrasound Gel, 5 Liters, Blue

GUDID 10660584000901

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: 10660584000901
• NIH Device Record Key: 96bbb448-11af-4753-a66c-1c1219f0816a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaGel™ Ultrasound Gel, 5 Liters, Blue
• Version Model Number: 5LTRGEL-B
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000901 [Primary]

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: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-10-18

On-Brand Devices [DynaGel™ Ultrasound Gel, 5 Liters, Blue]

• 10660584000901: 5LTRGEL-B
• 10660584000222: 5LTRGEL-B