| Primary Device ID | 00814703016806 |
| NIH Device Record Key | 8a47995b-8b66-473d-ae71-2d5ed5cc5489 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOLOX CONTOURA Ceramic Femoral Head |
| Version Model Number | 3206.28.000 |
| 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 |
| 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 HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814703016806 [Primary] |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
[00814703016806]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-24 |
| Device Publish Date | 2019-09-16 |
| 00814703016905 | Contura Femoral Head, 36mm head, +7mm head length |
| 00814703016899 | Contura Femoral Head, 36mm head, +3.5mm head length |
| 00814703016882 | Contura Femoral Head, 36mm head, Neu head length |
| 00814703016875 | Contura Femoral Head, 36mm head, -3.5mm head length |
| 00814703016868 | Contura Femoral Head, 32mm head, +7mm head length |
| 00814703016851 | Contura Femoral Head, 32mm head, +3.5mm head length |
| 00814703016844 | Contura Femoral Head, 32mm head, Neu head length |
| 00814703016837 | Contura Femoral Head, 32mm head, -3.5mm head length |
| 00814703016813 | Contura Femoral Head, 28mm head, +3.5mm head length |
| 00814703016806 | Contura Femoral Head, 28mm head, Neu head length |
| 00814703016790 | Contura Femoral Head, 28mm head, -3.5mm head length |