TruDenta Electrodes

GUDID 00857869005215

TruDenta Electrodes

Electromedical Products International, Inc.

Transcutaneous electrical stimulation electrode
Primary Device ID00857869005215
NIH Device Record Keycdc7593d-5ac7-42b3-af9b-4bf5fbb2d7ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruDenta Electrodes
Version Model NumberTruDenta Electrodes
Company DUNS610954729
Company NameElectromedical Products International, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857869005215 [Primary]
GS110857869005212 [Package]
Package: autobag [10 Units]
In Commercial Distribution
GS120857869005219 [Package]
Contains: 10857869005212
Package: case [30 Units]
In Commercial Distribution

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-06-30

Devices Manufactured by Electromedical Products International, Inc.

00857869005277 - Alpha-Stim Conducting Solution2021-12-08 Alpha-Stim Conducting Solution 50 ml
00857869005284 - Alpha-Stim Conducting Solution2021-12-08 Alpha-Stim Conducting Solution 250 ml
00857869005017 - Alpha-Stim AID2020-03-05 Alpha-Stim AID kit - China
00857869005208 - Alpha-Stim SCS2020-03-05 Alpha-Stim SCS kit
00857869005260 - Alpha-Stim AID2020-03-05 Alpha-Stim AID kit - US
00857869005000 - Alpha-Stim M2019-05-23 Alpha-Stim M kit - China
00857869005185 - Alpha-Stim PPM2019-05-23 Alpha-Stim PPM kit
00857869005192 - Alpha-Stim 1002019-05-23 Alpha-Stim 100 kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.