| Primary Device ID | 00814703012174 |
| NIH Device Record Key | 1e0a9008-558d-47f1-acb2-4c22a3667fa9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 28mm Femoral Head, 12/14 taper, +0mm offset |
| Version Model Number | 3200.28.000 |
| Company DUNS | 078416717 |
| Company Name | TOTAL JOINT ORTHOPEDICS, INC. |
| 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 |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814703012174 [Primary] |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
[00814703012174]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-22 |
| 00810094691790 - Klassic Knee Templates, Stem Extensions | 2025-05-22 Knee Templates, Stem Extensions |
| 00810094692322 - Spline Wrench, Closed | 2025-05-22 |
| 00810094692346 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 10 |
| 00810094692353 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 11 |
| 00810094692360 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 12 |
| 00810094692377 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 13 |
| 00810094692384 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 14 |
| 00810094692391 - Intramedullary Reamer, Revision | 2025-05-22 Intramedullary Reamer, Revision, Sz 15 |