| Primary Device ID | B390AR6500RBE1 |
| NIH Device Record Key | c1d50138-7a89-4ca1-964e-416baff98e64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed 5.0mm Cool Cut Round Bur, HL |
| Version Model Number | AR-64500RBE |
| 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 |