| Primary Device ID | 03760172650003 |
| NIH Device Record Key | 787f63ec-9fa0-4c72-a2f1-b035c7ca498b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APELEM |
| Version Model Number | PLATINUM dRF |
| Company DUNS | 268596533 |
| Company Name | APELEM |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760172650003 [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 | 2023-06-08 |
| Device Publish Date | 2016-05-23 |
| 03760172650430 | Remote controlled radiology system |
| 03760172650003 | Remote controlled radiology system |
| 03760172650508 | Remote Controlled Radiology System |
| 03760172650485 | Remote Controlled Radiology System |
| 03760172650447 | Remote controlled Radiology System |
| 03760172650409 | Remote Controlled Radiology System |