Superior Foam Electrodes 2"x4" Oval

GUDID 20660584000885

Bag of 10 electrode packs

Dynatronics Corporation

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 20660584000885
• NIH Device Record Key: b0292014-5e72-4edc-80c4-4feb269ae66f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Superior Foam Electrodes 2"x4" Oval
• Version Model Number: DSF2X4V-CS
• Company DUNS: 113399125
• Company Name: Dynatronics Corporation
• Device Count: 10
• 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

Customer Support Contacts

• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com
• Phone: 8008746251
• Email: info@dynatron.com

Device Dimensions

• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch
• Area/Surface Area: 6.8 Square inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10660584000888 [Unit of Use]
GS1	20660584000885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092546

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Superior Foam Electrodes 2"x4" Oval]

• 20660584000885: Bag of 10 electrode packs
• 10660584000888: DSF2X4V