Klassic BiPolar Head, 59 mm OD, 28 mm Head

GUDID 00814703012112

TOTAL JOINT ORTHOPEDICS, INC.

Femoral head bipolar component Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty
Primary Device ID00814703012112
NIH Device Record Keyd13e3562-b7fb-43a5-845f-5ad220ad2a60
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic BiPolar Head, 59 mm OD, 28 mm Head
Version Model Number3205.59.028
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

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814703012112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


[00814703012112]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

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