RiX70 DC RiX70 DC-100

GUDID 08055060430221

The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of teeth and adjacent structures.

TRIDENT SRL

Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital
Primary Device ID08055060430221
NIH Device Record Keycb98d87e-46db-400c-9a8e-e5eefa6694cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRiX70 DC
Version Model NumberWall mount long arm
Catalog NumberRiX70 DC-100
Company DUNS430142798
Company NameTRIDENT SRL
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(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]
GS108055060430221 [Primary]

FDA Product Code

EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer
EHDUnit, X-Ray, Extraoral With Timer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-15
Device Publish Date2020-09-07

On-Brand Devices [RiX70 DC]

08055060430221The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of
08055060430191The RiX 70 DC Mobile is an X-Ray source to produce intraoral images for the diagnosis of teeth a
08055060430177The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of
08055060430160The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of

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