| Primary Device ID | 04260502640005 |
| NIH Device Record Key | b4e02ad2-1655-4138-ada1-b3173ef9fcca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COMPACT 2 |
| Version Model Number | 1190 |
| Catalog Number | 1190-2-1000 |
| Company DUNS | 314629130 |
| Company Name | PROTEC GmbH & Co. KG |
| 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 | false |
| OTC Over-The-Counter | false |
| Handling Environment Temperature | Between 18 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260502640005 [Primary] |
| IXW | Processor, Radiographic-Film, Automatic |
| 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 | 2016-10-28 |
| 04260502640203 - PROGNOST XP | 2020-12-23 Basic diagnostic x-ray system table, non-powered |
| 04260502640210 - PROGNOST XP | 2020-12-23 Basic diagnostic x-ray system table, non-powered |
| 04260502640227 - PROGNOST XP | 2020-12-23 Basic diagnostic x-ray system table, non-powered |
| 04260502640234 - PROGNOST XP | 2020-12-23 Basic diagnostic x-ray system table, non-powered |
| 04260502640241 - PROGNOST XP | 2020-12-23 Basic diagnostic x-ray system table, non-powered |
| 04260502640258 - PROGNOST XPE | 2020-12-23 Basic diagnostic x-ray system table, powered |
| 04260502640265 - PROGNOST XPE | 2020-12-23 Basic diagnostic x-ray system table, powered |
| 04260502640272 - PROGNOST XPE | 2020-12-23 Basic diagnostic x-ray system table, powered |