DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE G0353109

GUDID 05710188035316

High frequency ultrasound probe

Cortex Technology ApS

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 05710188035316
• NIH Device Record Key: f2456a29-b23a-4914-9172-f050bd8959ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE
• Version Model Number: 09
• Catalog Number: G0353109
• 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	05710188035316 [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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-26

On-Brand Devices [DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE]

• 05710188035330: High frequency ultrasound probe
• 05710188035316: High frequency ultrasound probe
• 05710188035309: High frequency ultrasound probe
• 05710188035293: High frequency ultrasound probe