GUDID 06970341674175

CSN3304, electrode pad, 3x4cm oval, single snap, GMDASZ

GMDASZ manufacturing Co., Ltd.

Transcutaneous electrical stimulation electrode
Primary Device ID06970341674175
NIH Device Record Keye9cbe963-e472-4e22-acc8-9c7af8a85f6a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCSN3304
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
GS106970341674175 [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 Date2017-09-26

Devices Manufactured by GMDASZ manufacturing Co., Ltd.

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06970341670818 - NA2026-01-02
06970341670825 - NA2026-01-02
06970341674014 - NA2026-01-02
06970341674069 - NA2026-01-02

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