mocom M7E200310

GUDID 08033837931331

Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgical instruments able to resist to a temperature of at least 80°C.

CEFLA SOCIETA' COOPERATIVA

Ultrasonic-cleaning water bath
Primary Device ID08033837931331
NIH Device Record Key7e41df0c-1920-4d84-a681-944f689cf3eb
Commercial Distribution StatusIn Commercial Distribution
Brand Namemocom
Version Model NumberTethys H10
Catalog NumberM7E200310
Company DUNS429341410
Company NameCEFLA SOCIETA' COOPERATIVA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108033837931331 [Primary]

FDA Product Code

MECDisinfector, Medical Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-09-18
Device Publish Date2016-12-01