EzRay Air W

GUDID 08800016400465

Dental Extraoral Source X-ray System (Horizontal Arm Length 900mm)

VATECH CO., LTD.

Hand-held intraoral dental x-ray system, digital
Primary Device ID08800016400465
NIH Device Record Key5f6d488a-c46b-4f0c-a062-aae149c03fca
Commercial Distribution StatusIn Commercial Distribution
Brand NameEzRay Air W
Version Model NumberVEX-S300W
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108800016400465 [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 Number4
Public Version Date2024-02-19
Device Publish Date2017-06-30

On-Brand Devices [EzRay Air W]

08800016400656VEX-S300W X-RAY SYSTEM(450MM)(R5)/(EzRay Air W)(US)
08800016400649VEX-S300W X-RAY SYSTEM(600MM)(R5)/(EzRay Air W)(US)
08800016400632VEX-S300W X-RAY SYSTEM(900MM)(R5)/(EzRay Air W)(US)
08800016400489Dental Extraoral Source X-ray System (Horizontal Arm Length 450mm)
08800016400472Dental Extraoral Source X-ray System (Horizontal Arm Length 600mm)
08800016400465Dental Extraoral Source X-ray System (Horizontal Arm Length 900mm)

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