Primary Device ID | 08800016400458 |
NIH Device Record Key | 2cd4b393-e6c5-414f-842d-82fddc7d361d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PaX-i Insight |
Version Model Number | PCH-30CS |
Company DUNS | 689229516 |
Company Name | VATECH CO., LTD. |
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 86 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800016400458 [Primary] |
MUH | System,X-Ray,Extraoral Source,Digital |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2024-02-19 |
Device Publish Date | 2017-06-30 |
08800016400458 | Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition |
08800016400441 | Dental Digital X-ray Imaging System functioning Pano Image Acquisition |