i-Dixel

GUDID 04548213026951

J.MORITA MFG.CORP.

Basic diagnostic x-ray system application software
Primary Device ID04548213026951
NIH Device Record Key7f3952a3-aa1f-43fd-972c-7ff1423bfa42
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Dixel
Version Model Numberi-Dixel
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 -40 Degrees Celsius and 65 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 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104548213026951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

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 Date2017-02-12

On-Brand Devices [i-Dixel]

04548213030804i-Dixel
04548213026982i-Dixel
04548213026975i-Dixel
04548213026968i-Dixel
04548213026951i-Dixel
04548213026944i-Dixel
04548213026852i-Dixel
04548213026845i-Dixel
04548213026838i-Dixel
04548213026821i-Dixel
04548213026814i-Dixel
04548213026807i-Dixel
04548213026791i-Dixel
04548213026784i-Dixel
04548213026777i-Dixel
04548213026760i-Dixel
04548213025299i-Dixel
04548213025282i-Dixel
04548213025183i-Dixel
04548213025176i-Dixel
04548213024735i-Dixel
04548213024728i-Dixel
04548213024711i-Dixel
04548213024704i-Dixel
04548213024698i-Dixel

Trademark Results [i-Dixel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
I-DIXEL
I-DIXEL
85697169 4312736 Live/Registered
J. MORITA MANUFACTURING CORPORATION
2012-08-07
I-DIXEL
I-DIXEL
78399547 3130683 Dead/Cancelled
J. MORITA MFG. CORP.
2004-04-09

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