Primary Device ID | 00935712300004 |
NIH Device Record Key | 26229575-29a1-45b2-817d-ff917cfee572 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Micro-X |
Version Model Number | Rover |
Catalog Number | MXU-RV01 |
Company DUNS | 745943642 |
Company Name | MICRO-X LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00935712300004 [Primary] |
IZL | System, X-Ray, Mobile |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-08 |
Device Publish Date | 2020-08-31 |
00935712300004 | The device is designed to perform radiographic x-ray examinations on pediatric and adult patient |
09357123000013 | The device is designed to perform radiographic x-ray examinations on pediatric and adult patient |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MICRO-X 78426899 3004079 Dead/Cancelled |
Reprocessing Products Corp 2004-05-28 |
![]() MICRO-X 76207283 not registered Dead/Abandoned |
CARL-ZEISS-STIFTUNG 2001-02-09 |
![]() MICRO-X 75860717 2478593 Dead/Cancelled |
METRO LINK, INC. 1999-11-30 |
![]() MICRO-X 75311184 not registered Dead/Abandoned |
MICRO EXPERTS, INC. 1997-06-18 |
![]() MICRO-X 72368017 0907460 Dead/Expired |
ALARMTRONICS ENGINEERING, INC. 1970-08-14 |