| Primary Device ID | 10603295229773 |
| NIH Device Record Key | 9d74829b-94dc-47bd-95dc-16395a9f5bae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIGMA HIGH PERFORMANCE |
| Version Model Number | 9505-02-853 |
| Catalog Number | 950502853 |
| 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 |
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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 |
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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 |
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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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295229773 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
[10603295229773]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2018-09-24 |
| 10603295227762 | SIGMA HIGH PERFORMANCE FBT DRILL TOWER |
| 10603295229773 | SIGMA HIGH PERFORMANCE FIXED BEARING THICK INSERT TRIAL CASE |
| 10603295229766 | SIGMA HIGH PERFORMANCE ROTATING PLATFORM THICK INSERT TRIAL CASE |
| 10603295229544 | SIGMA HIGH PERFORMANCE FB CURVED PLUS INSERT TRIALS CASE |
| 10603295227700 | SIGMA HIGH PERFORMANCE FBT EVALUATION BULLET SIZE 4-6 |
| 10603295227694 | SIGMA HIGH PERFORMANCE FBT EVALUATION BULLET SIZE 1.5-3 |
| 10603295228837 | SIGMA HIGH PERFORMANCE ANTERIOR FIRST REMOVABLE STYLUS |
| 10603295227786 | SIGMA HIGH PERFORMANCE FBT STANDARD TIBIAL PUNCH GUIDE SIZE 5-6 |
| 10603295227779 | SIGMA HIGH PERFORMANCE FBT STANDARD TIBIAL PUNCH GUIDE SIZE 1.5-4 |