| Primary Device ID | 10603295226154 | 
| NIH Device Record Key | cb9d80cf-faf7-4c79-88b3-01eebfb14270 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SIGMA HIGH PERFORMANCE | 
| Version Model Number | 9505-01-408 | 
| Catalog Number | 950501408 | 
| 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 | 10603295226154 [Primary] | 
| HWT | TEMPLATE | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
Moist Heat or Steam Sterilization
[10603295226154]
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 |