DynaGel™ Ultrasound Gel, sample 7B0217

GUDID 10660584000895

Dynatronics Corporation

Topical coupling gel, non-sterile

• Primary Device ID: 10660584000895
• NIH Device Record Key: 529a54aa-450c-490b-8be8-367fdd9b97a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaGel™ Ultrasound Gel, sample
• Version Model Number: 7B0217
• Catalog Number: 7B0217
• 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: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000895 [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: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-11-18

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• 10660584000451 - Dynatron SmarTRAC: 2023-11-03
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• 10660584000079 - Dynatron® ion™ Small: 2023-10-26
• 10660584000086 - Dynatron® ion™ Medium: 2023-10-26
• 10660584000093 - Dynatron® ion™ Large: 2023-10-26
• 10660584000185 - Solaris Soundhead: 2023-10-26
• 10660584000192 - Solaris Soundhead: 2023-10-26