Primary Device ID | 04547410327342 |
NIH Device Record Key | 8470c9ac-37fa-40f0-93cf-e7b90e695c8f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FDR-2000BPY |
Version Model Number | POSITIONER KIT BPSY HA USA E |
Company DUNS | 713565195 |
Company Name | FUJIFILM CORPORATION |
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 | true |
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 | false |
OTC Over-The-Counter | false |
Phone | +018002728465 |
xxx@xxx.xxx |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04547410327342 [Primary] |
MUE | Full field digital,system,x-ray,mammographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-12-14 |
04547410336047 | The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the i |
04547410327342 | The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the i |