GUDID 06970341674700

electrode pad, 10*15cm, butterfly.

GMDASZ manufacturing Co., Ltd.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 06970341674700
• NIH Device Record Key: 4caeda60-67c2-46c4-a25e-9578aedb4a81
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NA
• 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	06970341670498 [Primary]
GS1	06970341674700 [Package]; Contains: 06970341670498; Package: PE bag [10 Units]; In Commercial Distribution

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: 2017-10-27

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