| Primary Device ID | B390KM35251 |
| NIH Device Record Key | c982cd95-75a9-44be-aa2a-6cb26722ad64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed Small Bone Osc Sagittal Blade, Thin, 31 x 9 x 0.38mm |
| Version Model Number | KM3-525 |
| 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 | B390KM35251 [Primary] |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
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