| Primary Device ID | 00814703011962 |
| NIH Device Record Key | 1f5bc91f-f395-4698-a350-c95ab2da0121 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Klassic BiPolar Head, 44 mm OD, 28 mm Head |
| Version Model Number | 3205.44.028 |
| 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 | 00814703011962 [Primary] |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
[00814703011962]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-22 |
| 00810094692131 - Distal Hip Reamer, Sz 6 | 2025-01-30 Distal Hip Reamer, Sz 6 |
| 00810094692148 - Distal Hip Reamer, Sz 7 | 2025-01-30 Distal Hip Reamer, Sz 7 |
| 00810094692155 - Distal Hip Reamer, Sz 8 | 2025-01-30 Distal Hip Reamer, Sz 8 |
| 00810094692162 - Distal Hip Reamer, Sz 9 | 2025-01-30 Distal Hip Reamer, Sz 9 |
| 00810094692179 - Distal Hip Reamer, Sz 10 | 2025-01-30 Distal Hip Reamer, Sz 10 |
| 00810094692186 - Distal Hip Reamer, Sz 11 | 2025-01-30 Distal Hip Reamer, Sz 11 |
| 00810094692193 - Distal Hip Reamer, Sz 12 | 2025-01-30 Distal Hip Reamer, Sz 12 |
| 00810094692209 - Distal Hip Reamer, Sz 13 | 2025-01-30 Distal Hip Reamer, Sz 13 |