Carbon-Rubber Electrodes (8" x 3")

GUDID 00861284002629

ELECTRO MEDICAL TECHNOLOGIES, LLC

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00861284002629
• NIH Device Record Key: dfc05fa0-4a20-4ef9-be08-8a50ed848b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carbon-Rubber Electrodes (8" x 3")
• Version Model Number: 8 x 3
• 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	00861284002629 [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: 2018-08-03
• Device Publish Date: 2018-07-03

On-Brand Devices [Carbon-Rubber Electrodes (8" x 3")]

• 00861284002629: 8 x 3
• B243PSRCR2102: Carbon-Rubber Electrodes (8" x 3") B243PSRCR2102