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 |
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 |
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
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 |