| Primary Device ID | B9875X10 |
| NIH Device Record Key | 906a7dc9-c162-4ced-9c75-f2a1a26abb89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radiochromic.com |
| Version Model Number | 5.1 |
| Company DUNS | 468141103 |
| Company Name | RADIOCHROMIC SL. |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B9875X10 [Primary] |
| MWW | Accessory - Film Dosimetry 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 | 2024-06-18 |
| Device Publish Date | 2024-06-10 |
| B9873X30 | Radiochromic film dosimetry and radiation therapy QA software |
| B9873X40 | Radiochromic film dosimetry and radiation therapy QA software |
| B9874X00 | Radiochromic film dosimetry and radiation therapy QA software |
| B9875X00 | Radiochromic film dosimetry and radiation therapy QA software |
| B9875X10 | Radiochromic film dosimetry and radiation therapy QA software |