| Primary Device ID | 08031497000725 |
| NIH Device Record Key | c5dacd8e-804f-4c24-a7ff-a1cf41de3957 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BONE INJECTION NEEDLE diamond tip 15 Gauge 120 mm length |
| Version Model Number | SPN1512 |
| Company DUNS | 435428396 |
| Company Name | TECRES SPA |
| 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 | false |
| OTC Over-The-Counter | false |
| 08031497003689 - Mendec® Kypho Set Monolateral 10 mm | 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend |
| 08031497003696 - Mendec® Kypho Set Monolateral 15 mm | 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend |
| 08031497003702 - Mendec® Kypho Set Monolateral 20 mm | 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend |
| 08031497003801 - Mendec® Kypho Set Bilateral 10 mm | 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend |
| 08031497003818 - Mendec® Kypho Set Bilateral 15 mm | 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend |
| 08031497003825 - Mendec® Kypho Set Bilateral 20 mm | 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend |
| 08031497002057 - 2Mix Gun | 2024-02-20 2Mix Gun is designed to aid the extrusion of bone cement from 2Mix. |
| 28031497001078 - 2Mix | 2024-02-20 2Mix is a medical device for mixing bone cement. The device includes several components: mixing container, mixing cap, cannula, |