| Primary Device ID | 00810094691813 |
| NIH Device Record Key | 74340f71-53f9-4b6f-ac54-e8ce4916974c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patella Drill Guide/Sizer, Klassic ONE |
| Version Model Number | SRI-10037-03 |
| Company DUNS | 078416717 |
| Company Name | TOTAL JOINT ORTHOPEDICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 801-486-6070 |
| udi@tjoinc.com | |
| Phone | 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 |
| 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 Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810094691813 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
[00810094691813]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-24 |
| Device Publish Date | 2023-08-16 |
| 00810094691813 | Patella Drill Guide/Sizer, 3-4 |
| 00810094691806 | Patella Drill Guide/Sizer, 1-2 |