| Primary Device ID | 10603295147831 | 
| NIH Device Record Key | ef117659-2413-4c3c-9da0-efa9f1e60d86 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | C-STEM | 
| Version Model Number | 258000059 | 
| Catalog Number | 258000059 | 
| 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 | 
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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 | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10603295147831 [Primary] | 
| FSM | TRAY, SURGICAL, INSTRUMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
Moist Heat or Steam Sterilization
[10603295147831]
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 | 
| 10603295235453 | C-STEM CANAL REAMER 20MM | 
| 10603295235446 | C-STEM CANAL REAMER 19MM | 
| 10603295235439 | C-STEM CANAL REAMER 18MM | 
| 10603295235422 | C-STEM CANAL REAMER 17MM | 
| 10603295235408 | C-STEM CANAL REAMER 16MM | 
| 10603295235385 | C-STEM CANAL REAMER 15MM | 
| 10603295235361 | C-STEM CANAL REAMER 14MM | 
| 10603295235347 | C-STEM CANAL REAMER 13MM | 
| 10603295235330 | C-STEM CANAL REAMER 12MM | 
| 10603295235323 | C-STEM CANAL REAMER 11MM | 
| 10603295235316 | C-STEM CANAL REAMER 10MM | 
| 10603295235309 | C-STEM CANAL REAMER 9MM | 
| 10603295235293 | C-STEM CANAL REAMER 8MM | 
| 10603295490654 | C-STEM AMT INCEMENT TRAY | 
| 10603295478409 | C-STEM AMT REVISION TRAY | 
| 10603295235903 | C-STEM INSTRUMENT CASE COMPLETE | 
| 10603295147855 | C-Stem AMT TRAY 2 | 
| 10603295147848 | C-Stem AMT TRAY 1 | 
| 10603295478423 | C-STEM AMT EXTENDED TRAY | 
| 10603295478416 | C-STEM AMT CORE TRAY | 
| 10603295490647 | C-STEM AMT BROACH SIZE 8 | 
| 10603295490630 | C-STEM AMT BROACH SIZE 7 | 
| 10603295490623 | C-STEM AMT BROACH SIZE 6 | 
| 10603295490616 | C-STEM AMT BROACH SIZE 5 | 
| 10603295490609 | C-STEM AMT BROACH SIZE 4 | 
| 10603295490593 | C-STEM AMT BROACH SIZE 3 | 
| 10603295490586 | C-STEM AMT BROACH SIZE 2 | 
| 10603295490579 | C-STEM AMT BROACH SIZE 1 | 
| 10603295490562 | C-STEM AMT BROACH SIZE 3A | 
| 10603295490555 | C-STEM AMT BROACH SIZE 2A | 
| 10603295490548 | C-STEM AMT BROACH SIZE 1A | 
| 10603295490531 | C-STEM AMT BROACH SIZE CDH | 
| 10603295235859 | C-STEM NECK SEGMENT SIZE 5 HI | 
| 10603295235828 | C-STEM NECK SEGMENT SIZE 4 HI | 
| 10603295235781 | C-STEM NECK SEGMENT SIZE 3 HI | 
| 10603295235743 | C-STEM NECK SEGMENT SIZE 2 HI | 
| 10603295235668 | C-STEM NECK RESECTION GUIDE | 
| 10603295147831 | C-Stem TO C-Stem AMT CONVERSION TRAY | 
| 10603295147824 | C-Stem AMT BROACH INSTRUMENT TRAY | 
| 10603295147800 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 8 | 
| 10603295147794 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 7 | 
| 10603295147787 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 6 | 
| 10603295147770 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 5 | 
| 10603295147763 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 4 | 
| 10603295147756 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 3 | 
| 10603295147749 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 2 | 
| 10603295147732 | C-STEM TO AMT HIGH NECK SEGMENT SIZE 1 | 
| 10603295147725 | C-STEM TO AMT STD NECK SEGMENT SIZE 8 | 
| 10603295147718 | C-STEM TO AMT STD NECK SEGMENT SIZE 7 | 
| 10603295147701 | C-STEM TO AMT STD NECK SEGMENT SIZE 6 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  C-STEM  98363961  not registered Live/Pending | COSMEDICAL TECHNOLOGIES, LLC 2024-01-18 | 
|  C-STEM  97052456  not registered Live/Pending | C-STEM Teacher and Student Support Services, Inc. 2021-09-29 | 
|  C-STEM  97052450  not registered Live/Pending | C-STEM Teacher and Student Support Services, Inc. 2021-09-29 | 
|  C-STEM  88918427  not registered Live/Pending | TREEFROG THERAPEUTICS 2020-05-15 | 
|  C-STEM  88918328  not registered Live/Pending | TREEFROG THERAPEUTICS 2020-05-15 | 
|  C-STEM  86248722  4637128 Live/Registered | Cosmedical Technologies, Inc. 2014-04-10 | 
|  C-STEM  85118916  3954504 Live/Registered | DePuy, Inc. 2010-08-30 | 
|  C-STEM  75262193  2284401 Live/Registered | Martin Industrial Service, Inc. 1997-03-24 |