| Primary Device ID | B390OM90101 |
| NIH Device Record Key | e039d8d6-2445-4a8d-88f0-8e8af2ba6962 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed 3.2mm, Opus Magnum Spade Drill |
| Version Model Number | OM-9010 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B390OM90101 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-03 |
| Device Publish Date | 2022-04-25 |
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