| Primary Device ID | 18032937160327 |
| NIH Device Record Key | d7d1c885-ce46-4954-bcf5-47b2b62fc6f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUELOK SYSTEM |
| Version Model Number | 1 |
| Catalog Number | 450500-08 |
| 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 | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Width | 65 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18032937160327 [Primary] |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
Moist Heat or Steam Sterilization
[18032937160327]
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 | 2018-04-28 |
| 18056099649667 | TL-HEX LONG STRUT L158MM-318MM STERILE |
| 18056099649650 | TL-HEX MEDIUM STRUT L114MM-184MM STERILE |
| 18056099649643 | TL-HEX SHORT STRUT L92MM-122MM STERILE |
| 18056099649629 | TL PLUS NYLON INSERT NUT (PACK OF 10) |
| 18056099649612 | TL PLUS WASHER 4 MM THICK (PACK OF 10) |
| 18056099649605 | TL PLUS FOOT&ANKLE KIT TRAY COMPLETE |
| 18056099649599 | TL PLUS FOOT&ANKLE KIT BASE |
| 18056099649582 | TL PLUS FOOT&ANKLE KIT LID |
| 18056099649575 | TL PLUS FOOT&ANKLE KIT TRAY EMPTY |
| 18056099649568 | TL PLUS 90° PLATE 3 HOLES |
| 18056099649551 | TL PLUS 90° PLATE 2 HOLES |
| 18056099649544 | TL PLUS 90° PLATE 1 HOLE |
| 18056099649537 | TL PLUS TWISTED PLATE 4 HOLES |
| 18056099649520 | TL PLUS TWISTED PLATE 3 HOLES |
| 18056099649513 | TL PLUS TWISTED PLATE 2 HOLES |
| 18056099649506 | TL PLUS NYLON INSERT NUT |
| 18056099649490 | TL PLUS THREADED HINGE ROD L30MM |
| 18056099649483 | TL PLUS NON LOCKABLE UNIVERSAL JOINT |
| 18056099649476 | TL PLUS HINGE MALE LOW PROFILE |
| 18056099649469 | TL PLUS HINGE MALE HIGH PROFILE |
| 18056099649452 | TL PLUS 90° HINGE LOW PROFILE |
| 18056099649445 | TL PLUS 90° HINGE HIGH PROFILE |
| 18056099649438 | TL PLUS HINGE FEMALE LOW PROFILE |
| 18056099649421 | TL PLUS HINGE FEMALE HIGH PROFILE |
| 18056099649414 | TL PLUS WASHER 4 MM THICK |
| 18056099649407 | TL PLUS TENSION LIMITER |
| 18056099649391 | TL PLUS X-WIRE WITHOUT OLIVE L300MM D1.5MM |
| 18056099649384 | TL PLUS X-WIRE WITH OLIVE L300MM D1.5MM |
| 18056099649377 | TL PLUS BAYONET WIRE WITHOUT OLIVE L300MM D1.5MM |
| 18056099649360 | TL PLUS BAYONET WIRE WITH OLIVE L300MM D1.5MM |
| 18054242517351 | TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L70MM STERILE |
| 18054242517344 | TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L200MM STERILE |
| 18054242517337 | TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L150MM STERILE |
| 18054242517320 | TRUELOK PLUS TELESCOPIC LINEAR DISTRACTOR L100MM STERILE |
| 18054242517313 | TL-HEX STRUT DIRECTION CLIP KIT (PACK OF 6) STERILE |
| 18054242517306 | TL-HEX STRUT NUMBER CLIP KIT (PACK OF 6) STERILE |
| 18054242517290 | TRUELOK PLUS HALF PIN QUICK CONNECT D6MM L180MM STERILE |
| 18054242517283 | TRUELOK PLUS HALF PIN QUICK CONNECT D5MM L180MM STERILE |
| 18054242517276 | TRUELOK PLUS HALF PIN QUICK CONNECT D4MM L180MM STERILE |
| 18054242517269 | TL-HEX EMERGENCY TAB KIT STERILE |
| 18054242517252 | TL-HEX 3/8 RING D200MM STERILE |
| 18054242517245 | TL-HEX 3/8 RING D180MM STERILE |
| 18054242517238 | TL-HEX 3/8 RING D160MM STERILE |
| 18054242517221 | TL-HEX 3/8 RING D140MM STERILE |
| 18054242517214 | TL-HEX 3/8 RING D120MM STERILE |
| 18054242517207 | TL-HEX 3/8 RING D100MM STERILE |
| 18054242517191 | TL-HEX MODULAR 5/8 RING D200MM STERILE |
| 18054242517184 | TL-HEX MODULAR 5/8 RING D180MM STERILE |
| 18054242517177 | TL-HEX MODULAR 5/8 RING D160MM STERILE |
| 18054242517160 | TL-HEX MODULAR 5/8 RING D140MM STERILE |