| Primary Device ID | B390EIC4835011 |
| NIH Device Record Key | dd69ff5c-ed29-4482-b0d6-0e7da98f7a2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed Reflex Ultra PTR PlasmaWand |
| Version Model Number | EIC4835-01 |
| Company DUNS | 785616934 |
| Company Name | SURETEK MEDICAL |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |