Distal Femoral Cut Guide, Fixed with Paddles

GUDID 00819251025935

Distal Femoral Cut Guide, Fixed 5 degrees with Paddles

TOTAL JOINT ORTHOPEDICS, INC.

Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable
Primary Device ID00819251025935
NIH Device Record Key3eb271aa-7cb8-4a79-86be-7a477dc190b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Femoral Cut Guide, Fixed with Paddles
Version Model Number2140.00.105
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]
GS100819251025935 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


[00819251025935]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

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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

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