ETEKCITY TENS Unit Electrode Pads(50x100mm)

GUDID 20817915020054

ETEKCITY CORPORATION

Transcutaneous electrical stimulation electrode
Primary Device ID20817915020054
NIH Device Record Key4bd5bf0b-b5fe-40d5-89d5-9684b3a07318
Commercial Distribution StatusIn Commercial Distribution
Brand NameETEKCITY TENS Unit Electrode Pads(50x100mm)
Version Model NumberETU-P12
Company DUNS079578783
Company NameETEKCITY CORPORATION
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 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
GS100817915020050 [Primary]
GS110817915020057 [Package]
Contains: 00817915020050
Package: Color Box [2 Units]
In Commercial Distribution
GS120817915020054 [Package]
Contains: 10817915020057
Package: Outer Carton [40 Units]
In Commercial Distribution

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 Date2019-09-30
Device Publish Date2019-09-20

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