| Primary Device ID | 18032568035216 |
| NIH Device Record Key | 00990336-0bcd-4b8b-8d7a-7e42553dd432 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XCALIBER EXTERNAL FIXATOR |
| Version Model Number | 1 |
| Catalog Number | 19200 |
| 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 | 18032568035216 [Primary] |
| JDW | Pin, Fixation, Threaded |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18032568035216]
Moist Heat or Steam Sterilization
[18032568035216]
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 | 2018-04-24 |
| 18032937169719 | UE XCALIBER ANKLE COMPLETE KIT |
| 18032937169702 | JP XCALIBER ANKLE COMPLETE KIT |
| 18032937169696 | UE XCALIBER METADIAPHYSEAL COMPLETE KIT |
| 18032937169689 | JP XCALIBER METADIAPHYSEAL COMPLETE KIT |
| 18032937167791 | US XCALIBER ANKLE COMPLETE KIT |
| 18032937167784 | US XCALIBER METADIAPHYSEAL COMPLETE KIT |
| 18032568867299 | XCALIBER/PROCALLUS HYBRID INSTRUMENTS STERIBOX, EMPTY |
| 18032568867282 | XCALIBER META-DIAPHYSEAL/ANKLE INSTRUMENTS STERIBOX, EMPTY |
| 18032568867213 | XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE |
| 18032568867206 | XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE |
| 18032568863352 | XCALIBER HYBRID KIT STERILE |
| 18032568863345 | XCALIBER ARTICULATED ANKLE KIT STERILE |
| 18032568863338 | SUPPLEMENTARY SCREW HOLDER (BARS AND CLAMPS) STERILE |
| 18032568863321 | XCALIBER DYNAMIC C/D UNIT STERILE |
| 18032568863307 | XCALIBER META-DIAPHYSEAL KIT STERILE |
| 18032568861617 | RADIOLUCENT ANKLE PIN GUIDE STERILE |
| 18032568861600 | CANNULATED DRILL BIT WITH WIRE D 3.2 MM LENGTH 150 MM STERILE |
| 18032568861358 | SUPPLEMENTARY SCREW HOLDER BAR RADIOLUCENT 150 MM |
| 18032568861341 | UNIVERSAL ALLEN WRENCH |
| 18032568861259 | SUPPLEMENTARY SCREW HOLDER |
| 18032568035216 | XCALIBER MANIPULATION FORCEPS |
| 18053504369752 | Spare part, not medical device, not for sale. Reported for registration of UDI direct marking. |