| Primary Device ID | 00195278703156 |
| NIH Device Record Key | 4aeacf11-4388-481a-85dd-6c3db3eaf0b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radiation Screen |
| Version Model Number | LMP1 |
| Company DUNS | 266062561 |
| Company Name | GE MEDICAL SYSTEMS |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00195278703156 [Primary] |
| IWX | Barrier, control panel, x-ray, movable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-06 |
| Device Publish Date | 2023-08-29 |
| 00198953109281 - Senographe Pristina | 2025-12-09 Senographe Pristina UDI |
| 10198953054311 - not applicable | 2025-12-08 UDI Software Pristina |
| 00198953076873 - SenoIris | 2025-12-02 SenoIris 1 SP5 Software and Manual |
| 00195278914026 - Senographe Pristina | 2025-01-17 Senographe Pristina UDI |
| 00195278925428 - Pristina Paddle | 2025-01-17 Small Square presurgical localization paddle - Labelled |
| 10195278901764 - Not Applicable | 2025-01-17 Software Pristina 9 - ISO file |
| 00195278866899 - not applicable | 2024-06-17 Software Pristina 8.4 - ISO file |
| 00195278719812 - not applicable | 2024-04-19 Software Pristina ME 9.2 - ISO file |