| Primary Device ID | 07611819334380 |
| NIH Device Record Key | e2adacdd-27ae-43e4-b325-101b4234e990 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LCP |
| Version Model Number | 03.113.012 |
| Catalog Number | 03113012 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819334380 [Direct Marking] |
| GS1 | 10886982072795 [Primary] |
| HIBCC | H679031130120 [Secondary] |
| HTJ | GAUGE, DEPTH |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
[07611819334380]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2016-12-31 |
| 07611819374362 | BENDING TEMPLATE/16 HOLES 4.5MM/5.5MM LCP & LC-DCP PLATE |
| H679238711S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 14H/LT-STER |
| H679238710S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 14H/RT-STER |
| H679238709S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 12H/LT-STER |
| H679238708S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 12H/RT-STER |
| H679238707S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 10H/LT-STER |
| H679238706S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 10H/RT-STER |
| H679238705S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 8H/LT-STER |
| H679238704S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 8H/RT-STER |
| H679238703S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 6H/LT-STER |
| H679238702S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 6H/RT-STER |
| H679238701S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 4H/LT-STER |
| H679238700S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 4H/RT-STER |
| H67904110851S0 | OI LCP VOLR CLMN DSTL RADIUS PL 7H HEAD/5H SHAFT/LT-STERILE |
| H67904110850S0 | OI LCP VOLR CLMN DSTL RADIUS PL 7H HEAD/5H SHAFT/RT-STERILE |
| H67904110841S0 | OI LCP VOLR CLMN DSTL RADIUS PL 7H HEAD/4H SHAFT/LT-STERILE |
| H67904110751S0 | OI LCP VOLR CLMN DSTL RADIUS PL 6H HEAD/5H SHAFT/LT-STERILE |
| H67904110741S0 | OI LCP VOLR CLMN DSTL RADIUS PL 6H HEAD/4H SHAFT/LT-STERILE |
| H67904110740S0 | OI LCP VOLR CLMN DSTL RADIUS PL 6H HEAD/4H SHAFT/RT-STERILE |
| 07611819248502 | 5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE |
| 07611819246607 | 4.3MM THREADED LCP(TM) DRILL GUIDE |
| 07611819274105 | THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES |
| 07611819174016 | 2.0MM LCP SOLID THREADED DRILL GUIDE |
| 07611819348714 | INSERTION HANDLE F/LCP PROX HUMERUS PLATE/STARDRIVE |
| H679031220010 | 2.8MM LCP(TM) DRILL GUIDE-LONG FOR 3.5MM LCP(TM) PLATES |
| 07611819969971 | PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-L |
| 07611819969957 | PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-R |
| 07611819334397 | COMPRESSION DRILL GUIDE F/3.5 MM LCP PERCUTANEOUS INSTR SYS |
| 07611819334380 | NEUTRAL DRILL GUIDE F/3.5MM LCP PERCUTANEOUS INSTR SYS |
| 07611819334366 | OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM |
| H679031119040 | DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/5.0MM |
| H679031119030 | DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/4.0MM |
| H679031119020 | DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/3.0MM |
| H679031119010 | DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/2.5MM |
| H679031119000 | DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/2.0MM |
| 07611819604735 | 1.8MM LCP SOLID THREADED DRILL GUIDE FOR 2.4MM LCP PLATES |
| 07611819604728 | 1.5MM LCP SOLID THREADED DRILL GUIDE FOR 2.0MM LCP PLATES |
| 07611819412828 | 2.0MM THREADED DRILL GUIDE FOR 2.7MM PEDIATRIC LCP HIP PL |
| 07611819888906 | 4.3MM THREADED DRILL GUIDE FOR 5.0MM PEDIATRIC LCP HIP PL |
| 07611819888890 | 2.8MM THREADED DRILL GUIDE FOR 3.5MM PEDIATRIC LCP HIP PL |
| H679239921S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 14H/246MM LT-STER |
| H679239920S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 14H/246MM RT-STER |
| H679239917S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 12H/220MM LT-STER |
| H679239916S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 12H/220MM RT-STER |
| H679239913S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 10H/194MM LT-STER |
| H679239912S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 10H/194MM RT-STER |
| H679239909S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 8H/168MM LT-STER |
| H679239908S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 8H/168MM RT-STER |
| H679239905S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 6H/142MM LT-STER |
| H679239904S0 | 3.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 6H/142MM RT-STER |