GUDID 06970341670443

4 pcs CSN2505 and 2 pcs DS1015 and 2 pcs CSN4306 and 2 pcs DS433

GMDASZ manufacturing Co., Ltd.

Transcutaneous electrical stimulation electrode
Primary Device ID06970341670443
NIH Device Record Key321f2c75-dc70-45f4-8c2c-1b54c2e7f4dd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCSN2505,DS1015,CSN4306,DS433
Company DUNS529401134
Company NameGMDASZ manufacturing Co., Ltd.
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 Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106970341670443 [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 Date2017-04-07

Devices Manufactured by GMDASZ manufacturing Co., Ltd.

06970341670863 - NA2024-05-07 diameter 32mm
06970341670870 - NA2024-05-07 diameter 50mm
06970341670894 - NA2024-05-07
06970341673529 - NA2024-05-07 60X170mm
6970341677084 - NA2018-07-06 Electrode pad, prewired, 1 pack of 4pcs, white cloth backing
06970341677527 - NA2018-07-06 dual snap electrode, dia. 22mm
06970341677510 - NA2018-07-06 dual snap electrode pad, dia. 18mm
6970341677046 - NA2018-07-06 electrode pad, 50x50mm square, prewired, foam backing

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