| Primary Device ID | 18053504360872 |
| NIH Device Record Key | 4b774269-0950-48ff-aab6-4419dea8658b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-Beam Fusion Beaming System |
| Version Model Number | 1 |
| Catalog Number | 187990C |
| Company DUNS | 438793622 |
| Company Name | ORTHOFIX SRL |
| 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18053504360872 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18053504360872]
Moist Heat or Steam Sterilization
[18053504360872]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-23 |
| 18053504360896 | G-BEAM KIT COMPLETE |
| 18053504360872 | G-BEAM STERILIZATION TRAY COMPLETE |
| 18053504360865 | G-BEAM STERILIZATION TRAY |
| 18053504360858 | CONICAL THREADED EXTRACTOR |
| 18053504360841 | RATCHETING T-HANDLE |
| 18053504360834 | WIRE GUIDE |
| 18053504360827 | SMALL EXTRACTION TOOL D5.4MM |
| 18053504360810 | LARGE EXTRACTION TOOL D7.4MM |
| 18053504360803 | LARGE HEX SCREWDRIVER 5MM |
| 18053504360797 | SMALL HEX SCREWDRIVER 4MM |
| 18053504360780 | DRILL GUIDE |
| 18053504360773 | LARGE GUIDEWIRE D2.8MM STERILE |
| 18053504360766 | SMALL GUIDEWIRE D1.9MM STERILE |
| 18053504360759 | SIZING GAUGE |
| 18053504360742 | LARGE STEPPED DRILL D5.1-7.5MM |
| 18053504360735 | SMALL STEPPED DRILL D4-5.5MM |
| 18053504360728 | G-BEAM STAINLESS STEEL END CAP HIGH COMPRESSION STERILE |
| 18053504360711 | G-BEAM STAINLESS STEEL END CAP LOW COMPRESSION STERILE |
| 18053504360704 | G-BEAM STAINLESS STEEL FUSION BEAM L170MM D5.4MM STERILE |
| 18053504360698 | G-BEAM STAINLESS STEEL FUSION BEAM L165MM D5.4MM STERILE |
| 18053504360681 | G-BEAM STAINLESS STEEL FUSION BEAM L160MM D5.4MM STERILE |
| 18053504360674 | G-BEAM STAINLESS STEEL FUSION BEAM L155MM D5.4MM STERILE |
| 18053504360667 | G-BEAM STAINLESS STEEL FUSION BEAM L150MM D5.4MM STERILE |
| 18053504360650 | G-BEAM STAINLESS STEEL FUSION BEAM L145MM D5.4MM STERILE |
| 18053504360643 | G-BEAM STAINLESS STEEL FUSION BEAM L140MM D5.4MM STERILE |
| 18053504360636 | G-BEAM STAINLESS STEEL FUSION BEAM L135MM D5.4MM STERILE |
| 18053504360629 | G-BEAM STAINLESS STEEL FUSION BEAM L130MM D5.4MM STERILE |
| 18053504360612 | G-BEAM STAINLESS STEEL FUSION BEAM L125MM D5.4MM STERILE |
| 18053504360605 | G-BEAM STAINLESS STEEL FUSION BEAM L120MM D5.4MM STERILE |
| 18053504360599 | G-BEAM STAINLESS STEEL FUSION BEAM L115MM D5.4MM STERILE |
| 18053504360582 | G-BEAM STAINLESS STEEL FUSION BEAM L110MM D5.4MM STERILE |
| 18053504360575 | G-BEAM STAINLESS STEEL FUSION BEAM L105MM D5.4MM STERILE |
| 18053504360568 | G-BEAM STAINLESS STEEL FUSION BEAM L100MM D5.4MM STERILE |
| 18053504360551 | G-BEAM STAINLESS STEEL FUSION BEAM L95MM D5.4MM STERILE |
| 18053504360544 | G-BEAM STAINLESS STEEL FUSION BEAM L90MM D5.4MM STERILE |
| 18053504360537 | G-BEAM STAINLESS STEEL FUSION BEAM L85MM D5.4MM STERILE |
| 18053504360520 | G-BEAM STAINLESS STEEL FUSION BEAM L80MM D5.4MM STERILE |
| 18053504360513 | G-BEAM STAINLESS STEEL FUSION BEAM L75MM D5.4MM STERILE |
| 18053504360506 | G-BEAM STAINLESS STEEL FUSION BEAM L70MM D5.4MM STERILE |
| 18053504360490 | G-BEAM STAINLESS STEEL FUSION BEAM L65MM D5.4MM STERILE |
| 18053504360483 | G-BEAM STAINLESS STEEL FUSION BEAM L60MM D.4MM STERILE |
| 18053504360476 | G-BEAM STAINLESS STEEL FUSION BEAM L55MM D5.4MM STERILE |
| 18053504360469 | G-BEAM STAINLESS STEEL FUSION BEAM L50MM D5.4MM STERILE |
| 18053504360452 | G-BEAM STAINLESS STEEL FUSION BEAM L200MM D7.4MM STERILE |
| 18053504360445 | G-BEAM STAINLESS STEEL FUSION BEAM L195MM D7.4MM STERILE |
| 18053504360438 | G-BEAM STAINLESS STEEL FUSION BEAM L190MM D7.4MM STERILE |
| 18053504360421 | G-BEAM STAINLESS STEEL FUSION BEAM L185MM D7.4MM STERILE |
| 18053504360414 | G-BEAM STAINLESS STEEL FUSION BEAM L180MM D7.4MM STERILE |
| 18053504360407 | G-BEAM STAINLESS STEEL FUSION BEAM L175MM D7.4MM STERILE |
| 18053504360391 | G-BEAM STAINLESS STEEL FUSION BEAM L170MM D7.4MM STERILE |