EzRay Air

GUDID 08800016400496

Dental Extraoral Source Portable X-ray System (SSD 200mm)

VATECH CO., LTD.

Hand-held intraoral dental x-ray system, digital
Primary Device ID08800016400496
NIH Device Record Key11fddcfa-03fc-4e20-b8d8-a7ef39476db2
Commercial Distribution Discontinuation2024-03-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEzRay Air
Version Model NumberVEX-P300
Company DUNS689229516
Company NameVATECH CO., LTD.
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

Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108800016400496 [Primary]

FDA Product Code

EHDUnit, X-Ray, Extraoral With Timer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-03-18
Device Publish Date2017-07-31

On-Brand Devices [EzRay Air]

08800016400694VEX-P300 PORTABLE X-RAY SYSTEM (R6) / (EzRay Air) (USA) (65kV 2.5mA 200MM / A004332
08800016400496Dental Extraoral Source Portable X-ray System (SSD 200mm)

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