ControlSeal Electrode Domes (Standard Size)

GUDID E10001

Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).

COAPT LLC

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 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: E10001
• NIH Device Record Key: 9c5e7447-3542-4210-b283-3fcf942836b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ControlSeal Electrode Domes (Standard Size)
• Version Model Number: 1
• Company DUNS: 078505297
• Company Name: COAPT LLC
• Device Count: 9
• 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: true
• Manufacturing Date: true
• 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
HIBCC	B618E1 [Primary]
HIBCC	B618E2 [Primary]
HIBCC	E10001 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223605

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: 2
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-01-09

On-Brand Devices [ControlSeal Electrode Domes (Standard Size)]

• E40001: Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyog
• E10001: Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyog