Carbon Rubber Electrode (4" cylinder)

GUDID 00861284002636

ELECTRO MEDICAL TECHNOLOGIES, LLC

Transcutaneous electrical stimulation electrode, single-use
Primary Device ID00861284002636
NIH Device Record Keyedcd06f3-6e22-4bf7-b447-abb5d155ae4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarbon Rubber Electrode (4" cylinder)
Version Model Number0
Company DUNS160641309
Company NameELECTRO MEDICAL TECHNOLOGIES, LLC
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861284002636 [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 Date2021-07-23
Device Publish Date2021-07-15

Devices Manufactured by ELECTRO MEDICAL TECHNOLOGIES, LLC

00861284002636 - Carbon Rubber Electrode (4" cylinder)2021-07-23
00861284002636 - Carbon Rubber Electrode (4" cylinder)2021-07-23
B243SSWP2010PLUS0 - WELLNESSPRO2019-10-23 Transcutaneous Electrical Nerve Stimulator for Pain. The WellnessPro 2010 Plus is designed to provide electrical stimulation, fo
00861284002605 - WellnessPro2019-10-23
00861284002629 - Carbon-Rubber Electrodes (8" x 3")2018-08-03
00861284002612 - Carbon-Rubber Electrodes (2" Round)2018-07-30
B243PSRCR2102 - Carbon-Rubber Electrodes (8" x 3")2018-07-06
B243PSRCR552 - Carbon-Rubber Electrodes (2" Round)2018-07-06
B243PSSA2X2PP4 - Self-Adhesive Electrode 2" x 2" Pro Pulse HD2018-07-06 Self-Adhesive Electrode

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