Primary Device ID | 10603295227694 |
NIH Device Record Key | bd636288-6e51-4af7-96d2-a76ff6e0f68f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SIGMA HIGH PERFORMANCE |
Version Model Number | 9505-02-053 |
Catalog Number | 950502053 |
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 |
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 |
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 | 10603295227694 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
Moist Heat or Steam Sterilization
[10603295227694]
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 |
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 |