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

GUDID 10660584000222

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	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

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