GUDID 06970341673529

60X170mm

GMDASZ manufacturing Co., Ltd.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 06970341673529
• NIH Device Record Key: 55b2b6a9-7028-49b2-899a-6d677d46795b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SBM1AN001
• 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: true
• 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	06970341673529 [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
• 06970341673529 - NA: 2024-05-0760X170mm
• 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