DEKA SMARTXIDE TETRA M118D1

GUDID 08057017760306

The Smartxide Tetra system consists in a carbon dioxide laser (CO2) with 50W 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	08057017760306
NIH Device Record Key	3fd402f3-eb0d-413f-8266-1374e015485b
Commercial Distribution Status	In Commercial Distribution
Brand Name	DEKA SMARTXIDE TETRA
Version Model Number	M118D1
Catalog Number	M118D1
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 -10 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 -10 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 -10 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 -10 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 -10 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 -10 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 -10 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 -10 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 -10 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 -10 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 -10 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	08057017760306 [Primary]

FDA Product Code

GEX	Powered Laser Surgical Instrument