| Primary Device ID | 10603295228172 |
| NIH Device Record Key | 5a368600-1b9f-44b7-b827-8d1ff121401c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIGMA LCS |
| Version Model Number | 9505-02-116 |
| Catalog Number | 950502116 |
| Company DUNS | 080506581 |
| Company Name | DEPUY ORTHOPAEDICS, INC. |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295228172 [Primary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
[10603295228172]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-03 |
| Device Publish Date | 2018-09-24 |
| 10603295227861 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE PIN IMPACTOR/EXTRACTOR |
| 10603295227922 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE THREADED PINS HEADED |
| 10603295227915 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE THREADED PINS |
| 10603295227892 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE QUICK DRILL PINS HEADED |
| 10603295227885 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE QUICK DRILL PINS |
| 10603295229650 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE INSERTION INSTRUMENT CASE |
| 10603295229629 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT HP DUOFIX INLAY TRAY |
| 10603295229346 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TIBIA PREP CASE |
| 10603295227298 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 7 |
| 10603295227281 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 6 |
| 10603295227274 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 5 |
| 10603295227267 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 4 |
| 10603295227250 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 3.5 |
| 10603295227243 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 3 |
| 10603295227236 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 2.5 |
| 10603295227229 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 2 |
| 10603295227212 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 1.5 |
| 10603295227205 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 1 |
| 10603295228868 | SIGMA LCS HIGH PERFORMANCE INSTRUMENTS DUOFIX REDUCED COLLAR PINS |
| 10603295228004 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT EVALUATION BULLET W/O PEGS SZ 1-3 |
| 10603295227991 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT EVALUATION BULLET W/O PEGS SZ 4-7 |
| 10603295227526 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE DUOFIX TIBIAL BULLET SZ 4-7 |
| 10603295227519 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE DUOFIX TIBIAL BULLET SZ 2-3.5 |
| 10603295227502 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE DUOFIX TIBIAL BULLET SZ 1-1.5 |
| 10603295227496 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT DRILL STOP |
| 10603295228875 | SIGMA LCS HP STERILE DUOFIX REDUCED COLLAR PINS |
| 10603295228226 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 30mm |
| 10603295228219 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 25mm |
| 10603295228202 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 22.5mm |
| 10603295228196 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 20mm |
| 10603295228189 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 17.5mm |
| 10603295228172 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 15mm |
| 10603295228165 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 12.5mm |
| 10603295228158 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT SPACER BLOCK 10mm |
| 10603295227557 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TRAY TRIAL SZ 4.5 |
| 10603295227489 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE TIBIAL TRAY HANDLE |
| 10603295227441 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT KEEL PUNCH IMPACT |
| 10603295227410 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT PUNCH NONCEMENTED SZ 4-7 |
| 10603295227403 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT PUNCH NONCEMENTED SZ 2 - 3 |
| 10603295227397 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT PUNCH NONCEMENTED SZ 1-1.5 |
| 10603295227380 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT PUNCH CEMENTED SZ 4-7 |
| 10603295227373 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT PUNCH CEMENTED SZ 2 - 3 |
| 10603295227366 | SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT PUNCH CEMENTED SZ 1-1.5 |