Veraviewepocs 3D F40

GUDID 04548213020416

J.MORITA MFG.CORP.

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID04548213020416
NIH Device Record Key8b1757ff-e446-417b-8b56-ab4a2fa3db08
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraviewepocs 3D F40
Version Model NumberX-550
Company DUNS693811465
Company NameJ.MORITA MFG.CORP.
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 Datefalse
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 TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104548213020416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-27

On-Brand Devices [Veraviewepocs 3D F40]

04548213020430X-550
04548213020416X-550

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