| Primary Device ID | 00840682143424 |
| NIH Device Record Key | 70f424ed-b823-4e2e-962e-3790349876a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Breast Spacer |
| Version Model Number | BSP1 |
| 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 | 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 |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682143424 [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 | 2019-05-31 |
| Device Publish Date | 2019-05-23 |
| 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 |
| 00195278719577 - Allia | 2023-12-18 Allia IGS3 UDI |
| 00195278719720 - Allia | 2023-12-18 Allia IGS 7 UDI |
| 00195278719744 - Allia | 2023-12-18 Allia IGS 7 OR UDI |