Acetabular Insert Trial

GUDID 00819251020633

Acetabular Insert Trial, 32mm ID, 50mm

TOTAL JOINT ORTHOPEDICS, INC.

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Primary Device ID00819251020633
NIH Device Record Keyd1294061-cefe-4c03-804f-688aaeb8cd81
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcetabular Insert Trial
Version Model Number1204.50.032
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 Usefalse
Lot Batchtrue
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

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819251020633 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


[00819251020633]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-05
Device Publish Date2023-11-27

On-Brand Devices [Acetabular Insert Trial]

00819251020701Acetabular Insert Trial, 36mm ID, 64mm
00819251020695Acetabular Insert Trial, 36mm ID, 62mm
00819251020688Acetabular Insert Trial, 36mm ID, 60mm
00819251020671Acetabular Insert Trial, 36mm ID, 58mm
00819251020664Acetabular Insert Trial, 36mm ID, 56mm
00819251020657Acetabular Insert Trial, 36mm ID, 54mm
00819251020640Acetabular Insert Trial, 36mm ID, 52mm
00819251020633Acetabular Insert Trial, 32mm ID, 50mm
00819251020626Acetabular Insert Trial, 32mm ID, 48mm

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