GUDID 06970341674649

10 pairs of electrodes

GMDASZ manufacturing Co., Ltd.

Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 06970341674649
• NIH Device Record Key: fd6a4796-aa47-4f70-a362-482b5612d21c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DT-HDW-COMP-10PK-LG
• 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	06970341674649 [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: 2026-01-01
• Device Publish Date: 2025-12-24

Devices Manufactured by GMDASZ manufacturing Co., Ltd.

• 06970341670542 - NA: 2026-01-02
• 06970341670740 - NA: 2026-01-02
• 06970341670764 - NA: 2026-01-02
• 06970341670771 - NA: 2026-01-02
• 06970341670818 - NA: 2026-01-02
• 06970341670825 - NA: 2026-01-02
• 06970341674014 - NA: 2026-01-02
• 06970341674069 - NA: 2026-01-02