Invotec Dual Channel Electrode 29-80500DC

GUDID 10818501020048

Invotec Dual Channel: The Laryngeal Surface Electrode is intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

INVOTEC INTERNATIONAL, INC.

Electromyographic endotracheal tube electrode

• Primary Device ID: 10818501020048
• NIH Device Record Key: c069e70d-fc1b-4a4a-bfa4-0ad0820e886a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invotec Dual Channel Electrode
• Version Model Number: 1
• Catalog Number: 29-80500DC
• Company DUNS: 622812592
• Company Name: INVOTEC INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818501020041 [Primary]
GS1	10818501020048 [Package]; Contains: 00818501020041; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122040

FDA Product Code

• ETN: Stimulator, Nerve

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-03

Devices Manufactured by INVOTEC INTERNATIONAL, INC.

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