DEKA SMARTXIDE TOUCH M110H1

GUDID 08057017760313

The smartxide Touch system consists in a carbon dioxide laser (CO2) with 60W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units.

EL.EN. SPA

General/multiple surgical carbon dioxide laser system

• Primary Device ID: 08057017760313
• NIH Device Record Key: 9291eb73-86f8-4e8c-a0e3-44cfcfef8a88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEKA SMARTXIDE TOUCH
• Version Model Number: M110H1
• Catalog Number: M110H1
• Company DUNS: 436887608
• Company Name: EL.EN. SPA
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057017760313 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[08057017760313]

Moist Heat or Steam Sterilization

[08057017760313]

Moist Heat or Steam Sterilization

[08057017760313]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-19
• Device Publish Date: 2019-03-15

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