Total Elbow 5003-000L

GUDID 07613327014006

Bearing Insert and Bushing

Howmedica Osteonics Corp.

Uncoated elbow humerus prosthesis
Primary Device ID07613327014006
NIH Device Record Key58dc9803-ffb6-4c09-870e-082962275a4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Elbow
Version Model Number5003-000L
Catalog Number5003-000L
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327014006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Total Elbow]

07613327014105Bearing Insert and Bushing
07613327014013Axle Pin
07613327014006Bearing Insert and Bushing
07613327013993Axle Pin

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