| Primary Device ID | 00819251021029 |
| NIH Device Record Key | 22d6470f-bc22-4fa3-8ccf-597b2fdd5d0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acetabular X-Ray Templates |
| Version Model Number | 1212.00.000 |
| 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 |
| 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 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| GS1 | 00819251021029 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
[00819251021029]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-15 |
| Device Publish Date | 2020-10-07 |
| 00819251026130 - Modular Tibial Broach, Klassic ONE | 2020-10-19 Modular Tibial Broach, Sz 1-2 |
| 00819251026147 - Modular Tibial Broach, Klassic ONE | 2020-10-19 Modular Tibial Broach, Sz 3-4 |
| 00819251026154 - Modular Tibial Broach, Klassic ONE | 2020-10-19 Modular Tibial Broach, Sz 5-6 |
| 00819251026161 - Tibial Broach Guide, Klassic ONE | 2020-10-19 Tibial Broach Guide |
| 00819251026192 - Patella Sizer/Clamp/Drill Guide/Reamer, Klassic ONE, Handle | 2020-10-19 Patella Sizer/Clamp/Drill Guide/Reamer, Handle |
| 00819251026208 - Patella Cement Clamp, Klassic ONE, Tip | 2020-10-19 Patella Cement Clamp, Tip |
| 00819251026222 - A/P Sizer, Klassic ONE | 2020-10-19 A/P Sizer |
| 00819251026239 - 3.5mm Hex Screwdriver, Klassic ONE | 2020-10-19 3.5mm Hex Screwdriver |