Dermascan C Ver. 3 USB A0390008

GUDID 05710188039000

Ultrasound imaging system main unit

Cortex Technology ApS

Ultrasound imaging system operator console

• Primary Device ID: 05710188039000
• NIH Device Record Key: b8e804ab-755d-422a-8d36-b165a93dc8b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermascan C Ver. 3 USB
• Version Model Number: 08
• Catalog Number: A0390008
• Company DUNS: 306186800
• Company Name: Cortex Technology ApS
• 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: true
• Manufacturing Date: false
• 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: +4598574100
• Email: cortex@cortex.dk

Device Identifiers

Device Issuing Agency	Device ID
GS1	05710188039000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983945

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-26

Devices Manufactured by Cortex Technology ApS

• 05710188020015 - CryoPro maxi: 2018-07-06 Cryosurgical device with accessories
• 05710188020022 - CryoPro mini: 2018-07-06 Cryosurgical equipment with accessories
• 05710188035293 - DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE: 2018-07-06 High frequency ultrasound probe
• 05710188035309 - DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE: 2018-07-06 High frequency ultrasound probe
• 05710188035316 - DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE: 2018-07-06 High frequency ultrasound probe
• 05710188035330 - DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE: 2018-07-06 High frequency ultrasound probe
• 05710188039000 - Dermascan C Ver. 3 USB: 2018-07-06Ultrasound imaging system main unit
• 05710188039000 - Dermascan C Ver. 3 USB: 2018-07-06 Ultrasound imaging system main unit