| Primary Device ID | B3901161701 |
| NIH Device Record Key | 2bc65a6a-83c3-4a0e-81b5-175e2cc02b13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed Mako Blade Standard, 2mm |
| Version Model Number | 116170 |
| Company DUNS | 785616934 |
| Company Name | SURETEK MEDICAL |
| 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 | 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 |