MedArt Intenz 620.000

GUDID 05700002070609

Medical CO2 laser system for soft tissue treatments.

Medart A/S

Dermatological carbon dioxide laser system

• Primary Device ID: 05700002070609
• NIH Device Record Key: d92c61ce-70aa-47fb-9f18-31d41fa461e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedArt Intenz
• Version Model Number: MedArt 620
• Catalog Number: 620.000
• Company DUNS: 305130079
• Company Name: Medart A/S
• 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: 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 Dimensions

• Weight: 20 Kilogram
• Height: 20 Centimeter
• Length: 60 Centimeter
• Depth: 45 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002070609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120573

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2019-02-07
• Device Publish Date: 2017-09-21