Green 18

GUDID 08800016400403

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition

VATECH CO., LTD.

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08800016400403
NIH Device Record Key312018f6-37a1-4700-9a5a-f9d48d3ea26c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGreen 18
Version Model NumberPHT-65LHS
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 HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800016400403 [Primary]

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

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 [Green 18]

08800016400410Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
08800016400403Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition

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