C-STEM 961221000
GUDID 10603295235958
C-STEM END CAP
DEPUY INTERNATIONAL LTD
Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer| Primary Device ID | 10603295235958 |
| NIH Device Record Key | 9a21c162-0080-446a-afee-0302c69fd230 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-STEM |
| Version Model Number | 9612-21-000 |
| Catalog Number | 961221000 |
| Company DUNS | 896498813 |
| Company Name | DEPUY INTERNATIONAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295235958 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K982918
FDA Product Code
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-02-08 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [C-STEM]
| 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 |
Trademark Results [C-STEM]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.