| Primary Device ID | 18032568869279 |
| NIH Device Record Key | 3bc463bb-3e9e-4950-844e-08569aea22d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREFIX FIXATOR |
| Version Model Number | 1 |
| Catalog Number | 19930 |
| 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 | 18032568869279 [Primary] |
| JDW | Pin, Fixation, Threaded |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18032568869279]
Moist Heat or Steam Sterilization
[18032568869279]
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 | 2018-04-19 |
| 18054242511403 | JP PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS |
| 18033509856518 | COMPLETE PREFIX II KIT |
| 18033509856174 | US PREFIX II ANKLE COMPLETE KIT STERILE |
| 18033509856167 | US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS |
| 18033509856150 | US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS |
| 18033509856143 | US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS |
| 18033509855979 | PREFIX II ANKLE COMPLETE KIT STERILE |
| 18033509855962 | PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS |
| 18033509855955 | PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS |
| 18033509855948 | PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS |
| 18033509851780 | TRANSFIXING PIN, THREAD L 80 MM STERILE SHAFT D 4MM, THREAD D 5MM |
| 18033509851773 | TRANSFIXING PIN, THREAD L 50 MM STERILE SHAFT D 4MM, THREAD D 5MM |
| 18032937168873 | ROD 900 MM LONG |
| 18032937168866 | ROD 800 MM LONG |
| 18032568869286 | PIN GUIDE |
| 18032568869279 | MULTI SCREW CLAMP GUIDE |
| 18032568869262 | MULTI SCREW CLAMP |
| 18032568868678 | ROD 500 MM LONG |
| 18032568868661 | ROD 400 MM LONG |
| 18032568867503 | TRANSFIXING PIN, THREAD L 50 MM SHAFT D 4MM, THREAD D 5MM |
| 18032568867480 | TRANSFIXING PIN CLAMP |
| 18032568867305 | PREFIX STERIBOX, EMPTY |
| 18032568867237 | SCREW CLIP CLAMP |
| 18032568867220 | ROD CLIP CLAMP |
| 18032568866568 | ROD 600 MM LONG |
| 18032568866186 | ROD 350 MM LONG |
| 18032568866179 | ROD 275 MM LONG |
| 18032568866162 | ROD 175 MM LONG |
| 18032568866155 | ROD 125 MM LONG |
| 18053504369899 | Spare part, not medical device, not for sale. Reported for registration of UDI direct marking. |