Easy@Home Self-Adhesive Reusable Electrodes

GUDID 10850253007786

EASY HEALTHCARE CORPORATION

Interferential electrical stimulation system electrode
Primary Device ID10850253007786
NIH Device Record Key8d9feb26-d6a7-46f8-bb5c-731d52c4128d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Self-Adhesive Reusable Electrodes
Version Model NumberETP101
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007789 [Primary]
GS110850253007786 [Package]
Contains: 00850253007789
Package: Carton [96 Units]
In Commercial Distribution
GS130850253007780 [Unit of Use]

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 Date2018-11-26
Device Publish Date2016-12-09

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