| Primary Device ID | 00819251020640 |
| NIH Device Record Key | 64ab74e5-fd1f-4529-8d1d-0a1078b98d3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acetabular Insert Trial |
| Version Model Number | 1204.52.036 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819251020640 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
[00819251020640]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-05 |
| Device Publish Date | 2023-11-27 |
| 00819251020701 | Acetabular Insert Trial, 36mm ID, 64mm |
| 00819251020695 | Acetabular Insert Trial, 36mm ID, 62mm |
| 00819251020688 | Acetabular Insert Trial, 36mm ID, 60mm |
| 00819251020671 | Acetabular Insert Trial, 36mm ID, 58mm |
| 00819251020664 | Acetabular Insert Trial, 36mm ID, 56mm |
| 00819251020657 | Acetabular Insert Trial, 36mm ID, 54mm |
| 00819251020640 | Acetabular Insert Trial, 36mm ID, 52mm |
| 00819251020633 | Acetabular Insert Trial, 32mm ID, 50mm |
| 00819251020626 | Acetabular Insert Trial, 32mm ID, 48mm |