| Primary Device ID | B390EICA4865011 |
| NIH Device Record Key | 346842d6-eb5e-4a70-8bc8-9185b76675ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed Reflex Ultra 65 PlasmaWand w/Cable |
| Version Model Number | EICA4865-01 |
| 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 |