DynaGel™ Ultrasound Gel, 5 Liters, Blue 5LTRGEL-B

GUDID 10660584000222

Dynatronics Corporation

Topical coupling gel, non-sterile

• Primary Device ID: 10660584000222
• NIH Device Record Key: 1d30e83b-abba-47d0-9f5d-ea17bdcbe244
• Commercial Distribution Discontinuation: 2019-03-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DynaGel™ Ultrasound Gel, 5 Liters, Blue
• Version Model Number: 5LTRGEL-B
• Catalog 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: false
• OTC Over-The-Counter: false

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	10660584000222 [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: 5
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-11-18

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

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