Distal Femoral Augment Trial

GUDID 00810094691745

Distal Femoral Augment Trial Size 5-6-7, 5mm

TOTAL JOINT ORTHOPEDICS, INC.

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Primary Device ID00810094691745
NIH Device Record Keyb2ee9408-313f-4dea-8dbf-b1ebb6f24dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Femoral Augment Trial
Version Model Number2810.05.005
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com
Phone801-486-6070
Emailudi@tjoinc.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094691745 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


[00810094691745]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-11
Device Publish Date2024-06-03

On-Brand Devices [Distal Femoral Augment Trial]

00810094691752Distal Femoral Augment Trial Size 5-6-7, 10mm
00810094691745Distal Femoral Augment Trial Size 5-6-7, 5mm
00810094691738Distal Femoral Augment Trial Size 3-4, 10mm
00810094691721Distal Femoral Augment Trial Size 3-4, 5mm
00810094691714Distal Femoral Augment Trial Size 1-2, 10mm
00810094691707Distal Femoral Augment Trial Size 1-2, 5mm

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