| Primary Device ID | B390AR8500HSO1 |
| NIH Device Record Key | ad373ad8-2f1b-452c-a7bc-d8788115bde4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed 5mm Hoodless Sheath, Oval Tapered |
| Version Model Number | AR-8500HSO |
| 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 | B390AR8500HSO1 [Primary] |
| NBH | Accessories, Arthroscopic |
| 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 |
| B39016005401 - Reprocessed Shaver Blade Straight 4.0mm Double Serrated | 2025-06-30 |
| B39062901120401 - Reprocessed 4mm Straight Shaver Blade | 2025-06-13 |
| B39062902080251 - Reprocessed 2.5mm Straight Shaver Blade | 2025-06-13 |
| B39072053121 - Reprocessed 3.5mm Incisor Blade | 2025-06-13 |
| B39016005381 - Reprocessed Shaver Blade Straight 3.0mm Double Serrated | 2025-06-09 |
| B39016010701 - Reprocessed Shaver Blade Straight 2.1mm Double Serrated | 2025-06-09 |
| B3902833091 - Reprocessed 3.5mm Full Radius Blade Plus | 2025-06-02 3.5mm Full Radius Blade Plus, Yellow |
| B3902834091 - Reprocessed 4.0mm Full Radius Blade Plus | 2025-06-02 4.0mm Full Radius Blade Plus, 13cm, Yellow |