| Primary Device ID | 18032568030587 |
| NIH Device Record Key | 054c9903-de42-41f8-950c-15e22244d2f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERTROCHANTERIC FIXATOR |
| Version Model Number | 1 |
| Catalog Number | 10048 |
| 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 | 18032568030587 [Primary] |
| JDW | Pin, Fixation, Threaded |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18032568030587]
Moist Heat or Steam Sterilization
[18032568030587]
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 | 2018-04-18 |
| 18032568032383 | TROCAR D 6 MM LENGTH 240 MM |
| 18032568032376 | TROCAR D 4.8 MM LENGTH 240 MM |
| 18032568032369 | SPECIAL SCREW GUIDE 150 MM FOR PERTROCHANTERIC FIXATOR |
| 18032568030631 | ROTATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR |
| 18032568030617 | DISTAL ROTATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR |
| 18032568030600 | ANGULATION LOCKING SCREW FOR PERTROCHANTERIC FIXATOR |
| 18032568030587 | PERTROCHANTERIC FIXATOR WITH ALLEN WRENCH 5 MM |
| 18053504366263 | Component. Not for sale. Used for reporting Direct Marking of assembly. |