06970341670894 Medical Device Identification

GUDID 06970341670894

GMDASZ manufacturing Co., Ltd.

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 ID	06970341670894
NIH Device Record Key	bb7c7073-95f7-49c8-8e71-6ce8241ade76
Commercial Distribution Status	In Commercial Distribution
Version Model Number	SBM1AD002
Company DUNS	529401134
Company Name	GMDASZ manufacturing Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970341670894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160138

FDA Product Code

GXY	Electrode, Cutaneous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-07
Device Publish Date	2024-04-29

Devices Manufactured by GMDASZ manufacturing Co., Ltd.

06970341670863 - NA	2024-05-07 diameter 32mm
06970341670870 - NA	2024-05-07 diameter 50mm
06970341670894 - NA	2024-05-07
06970341670894 - NA	2024-05-07
06970341673529 - NA	2024-05-07 60X170mm
6970341677084 - NA	2018-07-06 Electrode pad, prewired, 1 pack of 4pcs, white cloth backing
06970341677527 - NA	2018-07-06 dual snap electrode, dia. 22mm
06970341677510 - NA	2018-07-06 dual snap electrode pad, dia. 18mm
6970341677046 - NA	2018-07-06 electrode pad, 50x50mm square, prewired, foam backing