GUDID 00697034167740

CWN2505, electrode pad, 5x5cm, tan cloth, GMDASZ Mfg

GMDASZ manufacturing Co., Ltd.

Transcutaneous electrical stimulation electrode
Primary Device ID00697034167740
NIH Device Record Keybd308d1f-ea3b-4faf-b6b1-ed64ab030fbe
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCWN2505
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
GS100697034167740 [Package]
Contains: 06970341670283
Package: paper carton [630 Units]
In Commercial Distribution
GS106970341670283 [Primary]
GS106970341674410 [Package]
Contains: 06970341670283
Package: PE bag [10 Units]
In Commercial Distribution
GS106970341674434 [Package]
Contains: 06970341670283
Package: PE bag [2 Units]
In Commercial Distribution
GS106970341677305 [Package]
Contains: 06970341670283
Package: paper carton [420 Units]
In Commercial Distribution
GS106970341677336 [Package]
Contains: 06970341670283
Package: paper carton [600 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-26

Devices Manufactured by GMDASZ manufacturing Co., Ltd.

06970341670542 - NA2026-01-02
06970341670740 - NA2026-01-02
06970341670764 - NA2026-01-02
06970341670771 - NA2026-01-02
06970341670818 - NA2026-01-02
06970341670825 - NA2026-01-02
06970341674014 - NA2026-01-02
06970341674069 - NA2026-01-02

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