| Primary Device ID | 00195278560049 |
| NIH Device Record Key | 96bb3fbf-57e0-4a15-856c-6fb41db4af78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | PRISTINA 2.8 |
| Company DUNS | 266062561 |
| Company Name | GE MEDICAL SYSTEMS |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278560049 [Primary] |
| MUE | Full Field Digital, System, X-Ray, Mammographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-09 |
| Device Publish Date | 2022-12-01 |
| 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 |
| 00195278534064 - Spine Auto Views | 2024-03-19 Spine Auto Views Medical Device |
| 00195278795724 - not applicable | 2024-01-30 Software Pristina 8.3 - ISO file |
| 00195278719263 - Allia | 2023-12-18 Allia IGS5 UDI |