| Primary Device ID | 10603295228905 |
| NIH Device Record Key | 4763f2e4-036a-4b52-909f-8ab79b182409 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIGMA LCS HIGH PERFORMANCE |
| Version Model Number | 9505-02-302 |
| Catalog Number | 950502302 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 10603295228905 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2018-09-24 |
| 10603295227472 | SIGMA LCS HIGH PERFORMANCE MBT DRILL TOWER |
| 10603295228912 | SIGMA LCS HIGH PERFORMANCE STERILE THREADED HEADED PINS |
| 10603295228905 | SIGMA LCS HIGH PERFORMANCE INSTRUMENTS STERILE THREADED PINS |
| 10603295228882 | SIGMA LCS HIGH PERFORMANCE INSTRUMENTS STERILE QUICK DRILL PINS |
| 10603295227434 | SIGMA LCS HIGH PERFORMANCE MBT SPIKED EVALUATION BULLET SIZE 4-7 |
| 10603295227427 | SIGMA LCS HIGH PERFORMANCE MBT SPIKED EVALUATION BULLET SIZE 1-3 |
| 10603295227878 | SIGMA LCS HIGH PERFORMANCE POWER PIN DRIVER |
| 10603295227359 | SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 4-7 |
| 10603295227342 | SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 2-3 |
| 10603295227335 | SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 1-1.5 |
| 10603295227328 | SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 4-7 |
| 10603295227311 | SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 2-3 |
| 10603295227304 | SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 1-1.5 |