| Primary Device ID | 08031497003313 |
| NIH Device Record Key | cca1de2f-77ae-4f59-a997-0e722c085223 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MENDEC SPINE HV |
| Version Model Number | 12C20H1 |
| Company DUNS | 435428396 |
| Company Name | TECRES SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
|---|---|
| GS1 | 08031497003313 [Primary] |
| NDN | Cement, Bone, Vertebroplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2023-06-01 |
| 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, |
| 08031497003351 - TEKTONA HV US Bone Cement | 2023-06-16 TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty |
| 08031497003313 - MENDEC SPINE HV | 2023-06-09Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. The device is disposable and sterile. |
| 08031497003313 - MENDEC SPINE HV | 2023-06-09 Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures |
| 08031497002842 - MectaCem BonePrep | 2022-11-25 |
| 08031497002859 - MectaCem Bowl | 2022-11-25 |
| 08031497000695 - BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length | 2022-10-03 BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length with plastic handgrip intended for the injection of acrylic resin. |
| 08031497000701 - BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length | 2022-10-03 BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin. |