| Primary Device ID | 18032568033335 |
| NIH Device Record Key | 0295b96c-fbef-40d2-a1c6-6aa859cd34c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADULT LIMB RECONSTRUCTION SYSTEM |
| Version Model Number | 1 |
| Catalog Number | 14116 |
| 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 | 18032568033335 [Primary] |
| JDW | Pin, Fixation, Threaded |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18032568033335]
Moist Heat or Steam Sterilization
[18032568033335]
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 | 2018-04-10 |
| 18053504360919 | LRS SHORT SANDWICH CLAMP KIT |
| 18033509858093 | PLASTIC NUT FOR CD WITH CLICKER AND CD GARCHES (PACK OF 5 OF EACH) |
| 18032568866308 | 180MM ADULT LRS RAIL |
| 18032568864625 | OF-GARCHES T-CLAMP FOR ROTATIONAL CORRECTION |
| 18032568864618 | LRS TILTED CLAMP |
| 18032568864601 | EXTRA LONG RAIL LRS L.80 CM |
| 18032568864595 | EXTRA LONG RAIL LRS L.65 CM |
| 18032568864571 | LRS SHORT STRAIGHT CLAMP |
| 18032568864427 | LRS TILTED CLAMP TEMPLATE |
| 18032568036633 | LRS HINGED RAIL COUPLING |
| 18032568036626 | LRS MULTIPLANAR CLAMP |
| 18032568036602 | LRS WASHER |
| 18032568036596 | LRS LONG RAIL LENGTH 40 CM |
| 18032568036589 | LRS STANDARD RAIL LENGTH 30 CM |
| 18032568036572 | SANDWICH CLAMP WITH C/D UNIT FOR LRS |
| 18032568036565 | LRS OF-GARCHES T-CLAMP |
| 18032568036558 | LRS SHORT RAIL LENGTH 23 CM |
| 18032568036541 | LRS EXTRA SHORT RAIL LENGTH 12 CM |
| 18032568036534 | T-GARCHES CLAMP COUPLING |
| 18032568036527 | LRS BALL-JOINT COUPLING |
| 18032568036510 | LRS STRAIGHT CENTRAL CLAMP |
| 18032568036503 | DYNA-RING WITH C/D UNIT ATTACH FOR LRS |
| 18032568036497 | LRS DYNA-RING |
| 18032568036480 | LRS STRAIGHT OUTER CLAMP |
| 18032568036473 | LRS T-CLAMP |
| 18032568036459 | LRS SHORT KIT (23CM LONG) |
| 18032568036435 | LRS LONG KIT (40CM LONG) |
| 18032568036411 | LRS STANDARD KIT (30CM LONG) |
| 18032568036404 | CD UNIT FOR MICROMETRIC SWIVELLING CLAMP FOR LRS |
| 18032568036398 | MICROMETRIC SWIVELLING CLAMP FOR LRS |
| 18032568036374 | LONG C/D CLICKER MODEL |
| 18032568036367 | STANDARD C/D CLICKER MODEL |
| 18032568033458 | LRS SANDWICH CLAMP TEMPLATE |
| 18032568033441 | OF-GARCHES T-CLAMP TEMPLATE FOR LRS |
| 18032568033434 | CLAMP COUPLING TEMPLATE FOR LRS T-GARCHES |
| 18032568033427 | LRS ROTATIONAL TEMPLATE ARC RADIUS 130 MM |
| 18032568033410 | LRS ROTATIONAL TEMPLATE ARC RADIUS 100 MM |
| 18032568033403 | LRS TEMPLATE LOCKING SCREW FOR ACUTE CORRECTION |
| 18032568033397 | LRS TEMPLATE LOCKING SCREW FOR ACUTE ROTATION |
| 18032568033380 | LRS T-CLAMP TEMPLATE FOR ACUTE CORRECTION |
| 18032568033373 | LRS STRAIGHT CLAMP TEMPLATE FOR ACUTE CORRECTION |
| 18032568033366 | LRS OF-GARCHES TEMPLATE FOR ACUTE CORRECTION |
| 18032568033359 | LRS ROTATIONAL TEMPLATE |
| 18032568033342 | BALL-JOINT COUPLING TEMPLATE FOR LRS |
| 18032568033335 | LRS CLAMP TEMPLATE FOR MICROMETRIC SWIVELLING |
| 18032568033311 | LRS TEMPLATE LOCKING SCREW |
| 18032568033304 | LRS MULTIPLANAR CLAMP TEMPLATE |
| 18032568033298 | LRS T-CLAMP TEMPLATE |
| 18032568033281 | LRS STRAIGHT CLAMP TEMPLATE |
| 18032568032802 | ADULT L.R.S. STERI BOX EMPTY |