| Primary Device ID | 00857069006272 |
| NIH Device Record Key | 1162bd24-fa8b-4b10-8036-29908e8c6af3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Faxitron Core |
| Version Model Number | CoreVision 5x10 |
| Company DUNS | 968877360 |
| Company Name | FAXITRON BIOPTICS, LLC |
| 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 | 00857069006272 [Primary] |
| MWP | Cabinet, X-Ray System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-10 |
| Device Publish Date | 2019-07-02 |
| 00857069006265 - Faxitron OR | 2020-01-22 |
| 00857069006012 - Faxitron | 2020-01-22 Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excisions. |
| 00857069006029 - Faxitron | 2020-01-22 Mobile digital specimen x-ray system with 10x12.5 cm imager for the examination of Biopsy excisions. |
| 00857069006036 - Faxitron | 2020-01-22 Mobile digital specimen x-ray system with 10x10 cm imager for the examination of Biopsy excisions. |
| 00857069006043 - Faxitron | 2020-01-22 Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions. |
| 00857069006210 - Faxitron | 2020-01-22 Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions. |
| 00857069006272 - Faxitron Core | 2019-07-10 |
| 00857069006272 - Faxitron Core | 2019-07-10 |
| 00857069006289 - Faxitron Path | 2019-07-10 |