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 ID: 06970341670443
• NIH Device Record Key: 321f2c75-dc70-45f4-8c2c-1b54c2e7f4dd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CSN2505，DS1015，CSN4306，DS433
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970341670443 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-07

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
• 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