PROGNOST 7034-0-0000
GUDID 04260502640043
Basic x-ray system table, non-powered
PROTEC GmbH & Co. KG
Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered Basic diagnostic x-ray system table, non-powered| Primary Device ID | 04260502640043 |
| NIH Device Record Key | 85ad85e3-cdcf-4a66-b7ef-c133f276e998 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROGNOST |
| Version Model Number | XS |
| Catalog Number | 7034-0-0000 |
| Company DUNS | 314629130 |
| Company Name | PROTEC GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260502640043 [Primary] |
FDA Product Code
| KXJ | Table, Radiologic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-28 |
On-Brand Devices [PROGNOST ]
| 04260502640074 | Basic x-ray system table, powered |
| 04260502640067 | Basic x-ray system table, powered |
| 04260502640050 | Basic x-ray system table, non-powered |
| 04260502640043 | Basic x-ray system table, non-powered |
Trademark Results [PROGNOST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROGNOST 75898278 2661192 Live/Registered |
PROGNOST SYSTEMS GMBH 2000-01-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.