| Primary Device ID | 00842430101755 |
| NIH Device Record Key | f62464ac-776e-4468-84af-b0b29a9e6f5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pkit, STS Trios, GT, SG, Arm Pad |
| Version Model Number | 5808-1 |
| Catalog Number | 5808 |
| Company DUNS | 084527241 |
| Company Name | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00842430109140 - ADANTE KNEE PROCEDURE KIT, LEFT | 2025-08-05 Contains 6895TKA-L-CS Adante Knee Drape System, Left (case of 5) and 6895-75-5 Adante Knee Protection Kit (case of 5) |
| 00842430109157 - ADANTE KNEE PROCEDURE KIT, RIGHT | 2025-08-05 Contains 6895TKA-L-CS Adante Knee Drape System, Right (case of 5) and 6895-75-5 Adante Knee Protection Kit (case of 5) |
| 00842430109164 - ADANTE DAA HIP PROCEDURE KIT, LEFT | 2025-08-05 Contains 6895THA-L-CS Adante DAA-THA Drape, Left (case of 5) and 6895-76-5 Adante Hip Protection Kit (case of 5) |
| 00842430109171 - ADANTE DAA HIP PROCEDURE KIT, RIGHT | 2025-08-05 Contains 6895THA-R-CS Adante DAA-THA Drape, Right (case of 5) and 6895-76-5 Adante Hip Protection Kit (case of 5) |
| 00842430116728 - TRAPEZE ARM ASSEMBLY, PATIENT HELPER | 2025-08-05 |
| 00842430116261 - KIT, HANA SSXT MAQUET 1140 VERSION | 2025-01-20 |
| 10842430111539 - PKIT, INDIV W/SHEARGARD, SST-3000 (1) | 2024-05-20 |
| 00842430116322 - AQUARI IMMERSION CONTROLLER REFURB | 2024-03-15 |