Narcotrend Patient lead

GUDID 04260497025016

2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)

MT MonitorTechnik GmbH & Co. KG

Electroencephalographic monitoring system, portable Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system

• Primary Device ID: 04260497025016
• NIH Device Record Key: 6a7bda63-cf65-47a6-ac31-79266df12512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Narcotrend Patient lead
• Version Model Number: PKM4
• Company DUNS: 388136913
• Company Name: MT MonitorTechnik GmbH & Co. KG
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de
• Phone: +494192201753
• Email: info@monitortechnik.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260497025016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033543

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-09

On-Brand Devices [Narcotrend Patient lead]

• 04260497025016: 2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 0426049702106
• 04260497025009: 1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063