NewTom P70720008

GUDID 08033837931379

X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.

CEFLA SOCIETA' COOPERATIVA

Limited-view-field CT system
Primary Device ID08033837931379
NIH Device Record Keycc662afa-7733-4ee3-bb96-e26fff5d8a71
Commercial Distribution StatusIn Commercial Distribution
Brand NameNewTom
Version Model NumberNewTom 5G XL
Catalog NumberP70720008
Company DUNS437681152
Company NameCEFLA SOCIETA' COOPERATIVA
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

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
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 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 71 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108033837931379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-09
Device Publish Date2019-04-01