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.

Sweat-induction iontophoresis system
Primary Device ID03661540300370
NIH Device Record Key7ad48b5b-0fc8-4e2f-8f3d-7cc59ee2278e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMacroduct Advanced Electrode Cable Assembly
Version Model NumberAC-203
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com
Phone+1 (800) 435 2725
Emailinfo@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540300370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTBDevice, Iontophoresis, Specific Uses

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-15
Device Publish Date2021-06-07

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