C-STEM 961312000
GUDID 10603295236801
C-STEM Revision Stem - Length 240mm SIZE 8 9/10 TAPER CEMENTED
DEPUY (IRELAND)
Revision uncoated hip femur prosthesis| Primary Device ID | 10603295236801 |
| NIH Device Record Key | 15c75917-2c4a-4dea-aea1-373d90923149 |
| Commercial Distribution Discontinuation | 2022-07-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-STEM |
| Version Model Number | 9613-12-000 |
| Catalog Number | 961312000 |
| Company DUNS | 989365556 |
| Company Name | DEPUY (IRELAND) |
| 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 |
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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 |
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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 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295236801 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K982918
FDA Product Code
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| LZN | CEMENT OBTURATOR |
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 | 2022-06-22 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [C-STEM]
| 10603295060369 | C-STEM AMT Cemented Stem High Offset Size 8 12/14 TAPER |
| 10603295060352 | C-STEM AMT Cemented Stem High Offset Size 7 12/14 TAPER |
| 10603295060345 | C-STEM AMT Cemented Stem High Offset Size 6 12/14 TAPER |
| 10603295060338 | C-STEM AMT Cemented Stem High Offset Size 5 12/14 TAPER |
| 10603295060321 | C-STEM AMT Cemented Stem High Offset Size 4 12/14 TAPER |
| 10603295060307 | C-STEM AMT Cemented Stem High Offset Size 3 12/14 TAPER |
| 10603295060291 | C-STEM AMT Cemented Stem High Offset Size 2 12/14 TAPER |
| 10603295060284 | C-STEM AMT Cemented Stem High Offset SIZE 1 12/14 TAPER |
| 10603295059677 | C-STEM AMT Cemented Stem Standard Offset Size 8 12/14 TAPER |
| 10603295059660 | C-STEM AMT Cemented Stem Standard Offset Size 7 12/14 TAPER |
| 10603295059653 | C-STEM AMT Cemented Stem Standard Offset Size 6 12/14 TAPER |
| 10603295059646 | C-STEM AMT Cemented Stem Standard Offset Size 5 12/14 TAPER |
| 10603295059639 | C-STEM AMT Cemented Stem Standard Offset Size 4 12/14 TAPER |
| 10603295059615 | C-STEM AMT Cemented Stem Standard Offset Size 3 12/14 TAPER |
| 10603295059608 | C-STEM AMT Cemented Stem Standard Offset Size 2 12/14 TAPER |
| 10603295059592 | C-STEM AMT Cemented Stem Standard Offset SIZE 1 12/14 TAPER |
| 10603295236849 | C-STEM Stem High Offset SIZE 2 9/10 TAPER CEMENTED |
| 10603295236801 | C-STEM Revision Stem - Length 240mm SIZE 8 9/10 TAPER CEMENTED |
| 10603295236795 | C-STEM Revision Stem - Length 200mm SIZE 8 9/10 TAPER CEMENTED |
| 10603295236788 | C-STEM Revision Stem - Length 240mm SIZE 6 9/10 TAPER CEMENTED |
| 10603295236771 | C-STEM Revision Stem - Length 200mm SIZE 6 9/10 TAPER CEMENTED |
| 10603295236764 | C-STEM Revision Stem - Length 240mm SIZE 4 9/10 TAPER CEMENTED |
| 10603295236757 | C-STEM Revision Stem - Length 200mm SIZE 4 9/10 TAPER CEMENTED |
| 10603295235286 | C-STEM Stem High Offset SIZE 5 9/10 TAPER CEMENTED |
| 10603295235279 | C-STEM Stem High Offset SIZE 4 9/10 TAPER CEMENTED |
| 10603295235262 | C-STEM Stem High Offset SIZE 3 9/10 TAPER CEMENTED |
| 10603295235255 | C-STEM Stem SIZE 8 9/10 TAPER CEMENTED |
| 10603295235248 | C-STEM Stem SIZE 7 9/10 TAPER CEMENTED |
| 10603295235231 | C-STEM Stem SIZE 6 9/10 TAPER CEMENTED |
| 10603295235224 | C-STEM Stem SIZE 5 9/10 TAPER CEMENTED |
| 10603295235217 | C-STEM Stem SIZE 4 9/10 TAPER CEMENTED |
| 10603295235200 | C-STEM Stem SIZE 3 9/10 TAPER CEMENTED |
| 10603295235194 | C-STEM Stem SIZE 2 9/10 TAPER CEMENTED |
| 10603295235187 | C-STEM Stem SIZE 1 9/10 TAPER CEMENTED |
| 10603295235170 | C-STEM Stem SIZE CDH 9/10 TAPER CEMENTED |
| 10603295369523 | C-STEM AMT Cemented Stem High Offset Size 2 LONG 12/14 TAPER |
| 10603295369516 | C-STEM AMT Cemented Stem High Offset Size 3 LONG 12/14 TAPER |
| 10603295369509 | C-STEM AMT Cemented Stem Standard Offset Size 2 LONG 12/14 TAPER |
| 10603295369493 | C-STEM AMT Cemented Stem Standard Offset Size 3 LONG 12/14 TAPER |
| 10603295369486 | C-STEM AMT Cemented Stem Standard Offset Size 3 XL205 12/14 TAPER |
| 10603295369479 | C-STEM AMT Cemented Stem Standard Offset Size 1A 12/14 TAPER |
| 10603295369462 | C-STEM AMT Cemented Stem Standard Offset Size 2A 12/14 TAPER |
| 10603295369455 | C-STEM AMT Cemented Stem Standard Offset Size 3A 12/14 TAPER |
| 10603295369448 | C-STEM AMT Cemented Stem Standard Offset Size 3 XL240 12/14 TAPER |
| 10603295356226 | C-STEM AMT Cemented Stem Standard Offset CDH 12/14 TAPER |
| 10603295235460 | PEG FOR TRIAL C-STEM |
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 |
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