| Primary Device ID | 03760304680526 |
| NIH Device Record Key | 34f262dd-1c13-41c8-b880-918e29ae09b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MENIX DUO |
| Version Model Number | Meniscal suture system, 2 anchors |
| Catalog Number | MEN0201901 |
| Company DUNS | 772462123 |
| Company Name | S.B.M |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 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 |
|---|---|
| GS1 | 03760304680526 [Primary] |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-30 |
| Device Publish Date | 2023-08-22 |
| 03760304681332 - FIXIT / ecoFIX | 2024-09-26 Punch used with a FIXIT or ecoFIX implant for rotator cuff repair. |
| 03760304681080 - SBM | 2024-07-03 Complete instrumentation tray composed of reusable surgical instruments for extremity surgery. |
| 03760304681318 - SBM | 2024-07-03 250 x 250 sterilization basket lid |
| 03760304681325 - SBM | 2024-07-03 250 x 250 sterilization basket with silicone mat |
| 03760154001069 - OTIS-C-PLUS | 2024-06-28 Depth gauge for HTO. |
| 03760154005685 - LIGAFIX | 2024-06-28 Chondral pick for ACL reconstruction. |
| 03760154008167 - OTIS-F | 2024-06-28 Handle for the OTIS-F AO drill guide |
| 03760154008174 - OTIS-F | 2024-06-28 AO drill guide |