| Primary Device ID | 07630542713255 |
| NIH Device Record Key | fb0223de-aa3c-49e3-a3dc-f8eebffbb61d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mbrace System |
| Version Model Number | 01.23.0017 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| 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 | 07630542713255 [Primary] |
| JDQ | Cerclage, Fixation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-14 |
| Device Publish Date | 2024-05-06 |
| 07630345784582 - MyKnee | 2024-05-29 MyKnee Eff STYLUS FemDisCutBl-CT-GMK-LM-#3 |
| 07630542721939 - Spine Instruments | 2024-05-24 MUST LT countertorque for LP sleeve |
| 07630542730498 - Shoulder Instruments | 2024-05-24 GRS Central Screw Depth Checker |
| 07630542741326 - SportMeds Instruments | 2024-05-24 FastShuttle Side Loading |
| 07630542741333 - SportMeds Instruments | 2024-05-24 FastShuttle Side Loading - Humpback design |
| 07630542724008 - Knee Instruments | 2024-05-23 GMK Sphere/SpheriKA Ins Flex E-CROSS trial R tray |
| 07630030855306 - MyKnee UNI-ST | 2024-05-14 MyKnee UNI Tibia Bone Model LM - STERILE |
| 07630345724526 - Hip Instruments | 2024-05-14 Trial Mbrace GT Plate L45 mm |