| Primary Device ID | B216FB910A40K1 |
| NIH Device Record Key | 4a86820a-097d-40d0-ae99-b793f28fe262 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-CEL X-RAY CORPORATION |
| Version Model Number | FB910A-40K |
| Company DUNS | 062469945 |
| Company Name | ARQUILLA, INC. |
| 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 |
| Phone | 8154552470 |
| guido@xcelxray.com | |
| Phone | 8154552470 |
| guido@xcelxray.com |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B216FB910A40K1 [Primary] |
| KPR | System, X-Ray, Stationary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-06 |
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