TMR-ELEC-20201431 TRICOT HYPO Electrode

GUDID 00858688006599

Emsi

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use
Primary Device ID00858688006599
NIH Device Record Keya16a764a-b864-474a-b9b8-91173558678b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTMR-ELEC-20201431 TRICOT HYPO Electrode
Version Model NumberA1431
Company DUNS932471881
Company NameEmsi
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 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
GS100858688006599 [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 Date2016-09-22

Devices Manufactured by Emsi

00858688006964 - Electrode 45 x 45 16 PK2023-09-28
00858688006971 - Electrode 1.75 x 1.75 4 pack 2023-09-28
00859718007074 - Electrode 1.75 x 1.75 - 24 PK2023-09-28
00859718007081 - Electrode 4.0 x 7.0- Dispersive2023-09-28
00859718007098 - Electrode 1 Inch Round 4 PK2023-09-28
00859718007104 - Electrode 2" round 4pk2023-09-28
00859718007111 - Electrode 3 Inch Round 4PK2023-09-28
00859718007135 - Electrode 2 x 4 Inch Rectangle 2023-09-28

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