Carbon-Rubber Electrodes (2" Round)

GUDID B243PSRCR552

ELECTRO MEDICAL TECHNOLOGIES, LLC

Transcutaneous electrical stimulation electrode
Primary Device IDB243PSRCR552
NIH Device Record Keycda16d8b-d726-4040-99da-22d16ae2c169
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarbon-Rubber Electrodes (2" Round)
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB243PSRCR552 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Carbon-Rubber Electrodes (2" Round)]

00861284002612Carbon-Rubber Electrodes (2" Round) 00861284002612
B243PSRCR552Carbon-Rubber Electrodes (2" Round) B243PSRCR552

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