| Primary Device ID | 00868162000227 |
| NIH Device Record Key | f8f7d926-17a9-4e4f-a7f1-bc00688d9f23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SB-80-200R |
| Version Model Number | SB-80-200R |
| Catalog Number | 900086 |
| Company DUNS | 113928654 |
| Company Name | SOURCE-RAY, INC. |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 631-244-8200 |
| Ato@sourceray.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868162000227 [Primary] |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-09 |
| 00867538000311 - XRS-140-15K-P | 2022-02-28 X-ray Source Assembly, 140V, 15 mA- Pulsed |
| 00867538000328 - XRS-140-7.5K-P | 2022-02-24 X-Ray Source Assembly, 140V, 7.5mA, Pulsed |
| 00868162000289 - RC-115 | 2019-04-09 X-Ray Control, Remote |
| 00867538000304 - UC-5000 | 2018-07-06 Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiography, or Direct Digital Flat Panels |
| 00868162000234 - SR-115-CG | 2018-07-06 X-Ray Control / Generator, 100 kVp/ 15mA |
| 00868162000241 - SR-130-G | 2018-07-06 X-Ray Generator / Tube Housing Assembly, 100kVp / 30mA |
| 00868162000258 - SR-130-C | 2018-07-06 X-Ray Control, 100kVp / 30 mA |
| 00868162000265 - SR-1260-C | 2018-07-06 X-Ray Control, 120 kVp / 60mA |