Carbon-Rubber Electrodes (2" Round)

GUDID 00861284002612

ELECTRO MEDICAL TECHNOLOGIES, LLC

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00861284002612
• NIH Device Record Key: 929d7444-ff6d-477b-8c7b-4eefac24b1f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carbon-Rubber Electrodes (2" Round)
• Version Model Number: 0
• Company DUNS: 160641309
• Company Name: ELECTRO MEDICAL TECHNOLOGIES, LLC
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00861284002612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002227

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: 2018-07-30
• Device Publish Date: 2018-06-28

On-Brand Devices [Carbon-Rubber Electrodes (2" Round)]

• 00861284002612: Carbon-Rubber Electrodes (2" Round) 00861284002612
• B243PSRCR552: Carbon-Rubber Electrodes (2" Round) B243PSRCR552