Macroduct Advanced Electrode Cable Assembly

GUDID 03661540300370

The electrode cable assembly connects to the Macroduct Advanced inducer at the electrode connector on the top panel. Both electrodes, one red for the anode (positive) and one black for the cathode (negative), have a stainless-steel disc as the electrode plate. In the center of each electrode is a pin for detecting the Pilogel disc. The electrodes provide current from the device through the Pilogel discs to the patient skin during iontophoresis.

ELITECHGROUP INC.

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• Primary Device ID: 03661540300370
• NIH Device Record Key: 7ad48b5b-0fc8-4e2f-8f3d-7cc59ee2278e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macroduct Advanced Electrode Cable Assembly
• Version Model Number: AC-203
• Company DUNS: 052423787
• Company Name: ELITECHGROUP INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com
• Phone: +1 (800) 435 2725
• Email: info@elitechgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540300370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180627

FDA Product Code

• KTB: Device, Iontophoresis, Specific Uses

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-15
• Device Publish Date: 2021-06-07

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