Zynex Medical Electrodes

GUDID 00852670007076

Electrode 2” Round , 4 per Package

ZYNEX MEDICAL, INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00852670007076
NIH Device Record Key9193fdda-c67b-438e-af68-78e66dc5d1e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameZynex Medical Electrodes
Version Model Number300027
Company DUNS141582226
Company NameZYNEX MEDICAL, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852670007076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-01
Device Publish Date2018-10-01

On-Brand Devices [Zynex Medical Electrodes]

00852670007113Belt-Electrode Garment, Small/Medium
00852670007106Belt-Electrode Garment, Large/Extra Large
00852670007090Electrodes, 2” Square for LBG, 4pk
00852670007083NM900, Electrodes, 2" Round, 1 set of 3 electrodes.
00852670007076Electrode 2” Round , 4 per Package

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