| Primary Device ID | 18053504364832 |
| NIH Device Record Key | f0064035-be85-4f1d-9a58-b4fe570eea70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PELVIC FIXATOR |
| Version Model Number | 1 |
| Catalog Number | 111264 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18053504364832 [Primary] |
| HSB | Rod, Fixation, Intramedullary And Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18053504364832]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2019-04-19 |
| 18032568032833 | PELVIC FIXATOR STERI BOX EMPTY |
| 18032568030884 | CONNECTING UNIT FOR PELVIC FIXATOR |
| 18032568030877 | SUPPLEMENTARY LINK FOR PELVIC FIXATOR |
| 18032568030860 | PRIMARY LINK |
| 18032568030853 | PELVIC FIXATOR SHORT BODY |
| 18032568030846 | PELVIC FIXATOR LONG BODY |
| 18032568030839 | PELVIC FIXATOR LONG KIT WITH INDEP.SCREW PLACEMENT MODULES |
| 18032568030822 | PELVIC FIXATOR SHORT MODEL KIT |
| 18032568030815 | PELVIC FIXATOR LONG MODEL KIT |
| 18032568030655 | INDEPENDENT SCREW CLAMP |
| 18032568030648 | BALL-JOINTED MODULE FOR INDEPENDENT SCREW PLACEMENT |
| 18053504364856 | Component. Not for sale. Used for reporting Direct Marking of assembly. |
| 18053504364832 | Component. Not for sale. Used for reporting Direct Marking of assembly. |