Dynatron® ion™ Large

Basic Information

• Brand Name: Dynatron® ion™ Large
• Primary DI: 20660584000090
• Version / Model: ION-L
• Company Name: Dynatronics Corporation
• Labeler DUNS: 113399125
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-20
• Public Version: 4
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: 9e3b68e2-5c7a-49a0-8d2a-d25f63f702f1
• Distribution End Date: 2023-11-08

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	890.5525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46305	Iontophoresis system electrode, return	A non-sterile, non-active, electrical conductor that is fastened to a patient and connected to an iontophoresis system (e.g., typically the current generator), to create a circuit for the return of electrical current after its emission for the therapeutic transport of ions to the patient. It is fastened to the patient's body typically where the greatest effect can be achieved with respect to the active electrode. It will typically be designed with a detachable lead wire and comes in a variety of sizes. This is a single-use device.	No	Active
46304	Drug-delivery iontophoresis system electrode, active	A dedicated, active, electrical conductor that is a component of an iontophoresis system for transcutaneous drug delivery of a localized medication (e.g., corticosteroids or local anaesthetics). It is typically a layered pad that is attached to the skin surface of the patient at the target site, and connected to the current generator with a lead wire. An applied electric field causes the ionic-solution medication to transport from a reservoir within the pad for patient exposure. It comes in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20660584000090	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	2.8	Square inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 80.6 Degrees Fahrenheit