| Primary Device ID | 10603295226628 |
| NIH Device Record Key | c7e97b1f-02d6-4d27-b9c0-d5dab965b0da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIGMA PATHWAY |
| Version Model Number | 9505-01-527 |
| Catalog Number | 950501527 |
| 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 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| 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 | 10603295226628 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
[10603295226628]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-05-13 |
| Device Publish Date | 2018-09-24 |
| 10603295227137 | SIGMA PATHWAY SP2 TIBIAL ADAPTER |
| 10603295226680 | SIGMA PATHWAY FEMORAL 3 IN 1 SIZE 6 |
| 10603295226673 | SIGMA PATHWAY FEMORAL 3 IN 1 SIZE 5 |
| 10603295226666 | SIGMA PATHWAY FEMORAL 3 IN 1 SIZE 4 |
| 10603295226659 | SIGMA PATHWAY FEMORAL 3 IN 1 SIZE 3 |
| 10603295226642 | SIGMA PATHWAY FEMORAL 3 IN 1 SIZE 2.5 |
| 10603295226635 | SIGMA PATHWAY FEMORAL 3 IN 1 SIZE 2 |
| 10603295226628 | SIGMA PATHWAY FEMORAL 3 IN 1 SIZE 1.5 |
| 10603295227151 | SIGMA PATHWAY DISTAL FEMORAL CUTTING BLOCK |
| 10603295226765 | SIGMA PATHWAY ANTERIOR JIG ASSEMBLY |
| 10603295224778 | SIGMA PATHWAY FEMORAL CHAMFER BLOCK SIZE 6 |
| 10603295224259 | SIGMA PATHWAY ANTERIOR DOWN FEMORAL SIZING GUIDE |