DynaGel™ Ultrasound Gel, 5 Liters, Blue
GUDID 10660584000901
Dynatronics Corporation
Topical coupling gel, non-sterile| 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 |
Trademark Results [DynaGel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYNAGEL 75283357 2291896 Dead/Cancelled |
DynaGel Incorporated 1997-04-29 |
 DYNAGEL 73265092 1189041 Dead/Cancelled |
J. T. Baker Chemical Company 1980-06-05 |
 DYNAGEL 73027310 1022635 Dead/Expired |
APACHE POWDER COMPANY 1974-07-22 |
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