Tibial Insert Trial, Klassic ONE

GUDID 00819251027267

Tibial Insert Trial, size 4, 18mm

TOTAL JOINT ORTHOPEDICS, INC.

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Primary Device ID00819251027267
NIH Device Record Key6b31bb82-b4cd-416a-8dbb-f15c70990068
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Insert Trial, Klassic ONE
Version Model Number2240.04.018
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
Phone+1(801)486-6070
Emailudi@tjoinc.com

Device Dimensions

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
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
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
GS100819251027267 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


[00819251027267]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-19
Device Publish Date2020-10-09

On-Brand Devices [Tibial Insert Trial, Klassic ONE ]

00819251027403Tibial Insert Trial, size 6, 18mm
00819251027397Tibial Insert Trial, size 6, 16mm
00819251027380Tibial Insert Trial, size 6, 14mm
00819251027373Tibial Insert Trial, size 6, 13mm
00819251027366Tibial Insert Trial, size 6, 12mm
00819251027359Tibial Insert Trial, size 6, 11mm
00819251027342Tibial Insert Trial, size 6, 10mm
00819251027335Tibial Insert Trial, size 5, 18mm
00819251027328Tibial Insert Trial, size 5, 16mm
00819251027311Tibial Insert Trial, size 5, 14mm
00819251027304Tibial Insert Trial, size 5, 13mm
00819251027298Tibial Insert Trial, size 5, 12mm
00819251027281Tibial Insert Trial, size 5, 11mm
00819251027274Tibial Insert Trial, size 5, 10mm
00819251027267Tibial Insert Trial, size 4, 18mm
00819251027250Tibial Insert Trial, size 4, 16mm
00819251027243Tibial Insert Trial, size 4, 14mm
00819251027236Tibial Insert Trial, size 4, 13mm
00819251027229Tibial Insert Trial, size 4, 12mm
00819251027212Tibial Insert Trial, size 4, 11mm
00819251027205Tibial Insert Trial, size 4, 10mm
00819251027199Tibial Insert Trial, size 3, 18mm
00819251027182Tibial Insert Trial, size 3, 16mm
00819251027175Tibial Insert Trial, size 3, 14mm
00819251027168Tibial Insert Trial, size 3, 13mm
00819251027151Tibial Insert Trial, size 3, 12mm
00819251027144Tibial Insert Trial, size 3, 11mm
00819251027137Tibial Insert Trial, size 3, 10mm
00819251027120Tibial Insert Trial, size 2, 18mm
00819251027113Tibial Insert Trial, size 2, 16mm
00819251027106Tibial Insert Trial, size 2, 14mm
00819251027090Tibial Insert Trial, size 2, 13mm
00819251027083Tibial Insert Trial, size 2, 12mm
00819251027076Tibial Insert Trial, size 2, 11mm
00819251027069Tibial Insert Trial, size 2, 10mm
00819251027052Tibial Insert Trial, size 1, 18mm
00819251027045Tibial Insert Trial, size 1, 16mm
00819251027038Tibial Insert Trial, size 1, 14mm
00819251027021Tibial Insert Trial, size 1, 13mm
00819251027014Tibial Insert Trial, size 1, 12mm
00819251027007Tibial Insert Trial, size 1, 11mm
00819251026994Tibial Insert Trial, size 1, 10mm

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