| Primary Device ID | 10603295224181 |
| NIH Device Record Key | 1cec9cea-66cd-46c7-bb12-b917f451049d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIGMA HIGH PERFORMANCE |
| Version Model Number | 9505-01-004 |
| Catalog Number | 950501004 |
| Company DUNS | 896498813 |
| Company Name | DEPUY INTERNATIONAL LTD |
| 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 | |
| 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 | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295224181 [Primary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
Moist Heat or Steam Sterilization
[10603295224181]
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 |
| 10603295230168 | SIGMA HIGH PERFORMANCE 150 FLEX SHIM |
| 10603295226239 | SIGMA HIGH PERFORMANCE 150 CLASSIC AP BLOCK SIZE 6 |
| 10603295226222 | SIGMA HIGH PERFORMANCE 150 CLASSIC AP BLOCK SIZE 5 |
| 10603295226215 | SIGMA HIGH PERFORMANCE 150 CLASSIC AP BLOCK SIZE 4 |
| 10603295226208 | SIGMA HIGH PERFORMANCE 150 CLASSIC AP BLOCK SIZE 3 |
| 10603295226192 | SIGMA HIGH PERFORMANCE 150 CLASSIC AP BLOCK SIZE 2.5 |
| 10603295226185 | SIGMA HIGH PERFORMANCE 150 CLASSIC AP BLOCK SIZE 2 |
| 10603295226178 | SIGMA HIGH PERFORMANCE 150 CLASSIC AP BLOCK SIZE 1.5 |
| 10603295226154 | SIGMA HIGH PERFORMANCE 150 FIXED REFERENCE AP BLOCK SIZE 6 |
| 10603295226147 | SIGMA HIGH PERFORMANCE 150 FIXED REFERENCE AP BLOCK SIZE 5 |
| 10603295226130 | SIGMA HIGH PERFORMANCE 150 FIXED REFERENCE AP BLOCK SIZE 4 |
| 10603295226123 | SIGMA HIGH PERFORMANCE 150 FIXED REFERENCE AP BLOCK SIZE 3 |
| 10603295226116 | SIGMA HIGH PERFORMANCE 150 FIXED REFERENCE AP BLOCK SIZE 2.5 |
| 10603295226109 | SIGMA HIGH PERFORMANCE 150 FIXED REFERENCE AP BLOCK SIZE 2 |
| 10603295226093 | SIGMA HIGH PERFORMANCE 150 FIXED REFERENCE AP BLOCK SIZE 1.5 |
| 10603295225393 | SIGMA HIGH PERFORMANCE DISTAL FEMORAL ALIGN GUIDE |
| 10603295224952 | SIGMA HIGH PERFORMANCE MI 0 DEGREE HANDED TIBIAL CUTTING BLOCK RIGHT |
| 10603295224945 | SIGMA HIGH PERFORMANCE MI 0 DEGREE HANDED TIBIAL CUTTING BLOCK LEFT |
| 10603295224921 | SIGMA HIGH PERFORMANCE HANDED FEMORAL ANTERIOR JIG LEFT/RIGHT |
| 10603295224204 | SIGMA HIGH PERFORMANCE FEMORAL NOTCH GUIDE SIZE 6 |
| 10603295224198 | SIGMA HIGH PERFORMANCE FEMORAL NOTCH GUIDE SIZE 5 |
| 10603295224181 | SIGMA HIGH PERFORMANCE FEMORAL NOTCH GUIDE SIZE 4 |
| 10603295224174 | SIGMA HIGH PERFORMANCE FEMORAL NOTCH GUIDE SIZE 3 |
| 10603295224167 | SIGMA HIGH PERFORMANCE FEMORAL NOTCH GUIDE SIZE 2.5 |
| 10603295224150 | SIGMA HIGH PERFORMANCE FEMORAL NOTCH GUIDE SIZE 2 |
| 10603295224143 | SIGMA HIGH PERFORMANCE FEMORAL NOTCH GUIDE SIZE 1.5 |