DAEHAN Disposable cup electrode

GUDID 08800036901829

DAEHAN Disposable CUP Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography(EMG), Electroencephalograph (EEG) and Evoked potentials(EP).

DAEHAN MEDICAL SYSTEMS CO., LTD

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

• Primary Device ID: 08800036901829
• NIH Device Record Key: 2f9f2855-99ef-4b0f-9e64-beef13dee8fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAEHAN Disposable cup electrode
• Version Model Number: DCW 30C
• Company DUNS: 688038491
• Company Name: DAEHAN MEDICAL SYSTEMS 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800036901829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180232

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: 2019-12-23
• Device Publish Date: 2019-12-13