| Primary Device ID | 08054890480000 |
| NIH Device Record Key | bbb79bb7-7e27-465a-bda9-718f1eec4beb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPERA SWING |
| Version Model Number | X-RAY R&F REMOTE SYSTEM OPERA SWING |
| Company DUNS | 428658934 |
| Company Name | GENERAL MEDICAL MERATE SPA |
| 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 |
| Weight | 1120 Kilogram |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08054890480000 [Primary] |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-10 |
| Device Publish Date | 2016-09-22 |
| 08054890480048 | It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid sta |
| 08054890480031 | The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism whi |
| 08054890480017 | The device is a R&F remote tilting table which allows the execution of longitudinal, trasversal |
| 08054890480000 | The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiograph |