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 General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system
Primary Device ID08057017760313
NIH Device Record Key9291eb73-86f8-4e8c-a0e3-44cfcfef8a88
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEKA SMARTXIDE TOUCH
Version Model NumberM110H1
Catalog NumberM110H1
Company DUNS436887608
Company NameEL.EN. SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108057017760313 [Primary]
GS108057017760313 [Primary]
GS108057017760313 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08057017760313]

Moist Heat or Steam Sterilization


[08057017760313]

Moist Heat or Steam Sterilization


[08057017760313]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2019-03-15

Devices Manufactured by EL.EN. SPA

08057017760290 - DEKA SMARTXIDE TETRA2020-05-26 The Smartxide TETRA system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delive
08057017760306 - DEKA SMARTXIDE TETRA2020-05-26 The Smartxide Tetra system consists in a carbon dioxide laser (CO2) with 50W of maximum power. The CO2 laser radiation is delive
08057017760313 - DEKA SMARTXIDE TOUCH2020-05-19The 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.
08057017760313 - DEKA SMARTXIDE TOUCH2020-05-19 The smartxide Touch system consists in a carbon dioxide laser (CO2) with 60W of maximum power. The CO2 laser radiation is delive
08057017760450 - Elite iQ2020-03-23 The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite
08057017760467 - Elite iQ2020-03-23 The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite
08057017760511 - NEAUVIA CELL2020-03-16 The NEAUVIA CELL is a medical device that used high frequency RF currents to produce a localized increase in temperature in subc
08057017760504 - ECHOLASER X42020-02-24 The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam
08057017760221 - DEKA Motus AX2020-02-06 The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers the laser output

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