Modular Elbow 5005-U-080R

GUDID 07613327138450

Ulna Component

Howmedica Osteonics Corp.

Coated elbow humerus prosthesis
Primary Device ID07613327138450
NIH Device Record Keyc4ad91e0-5788-4820-9267-f32795fc9000
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Elbow
Version Model Number5005-U-080R
Catalog Number5005-U-080R
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 Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327138450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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 [Modular Elbow]

07613327139303Humeral Assembly
07613327139266Bearing, Bushing and Axle Kit
07613327139211Humeral Assembly
07613327139204Total Humeral Component
07613327139198Humeral Assembly
07613327139181Humeral Assembly
07613327139167Total Humeral Component
07613327138498Ulna Component
07613327138481Ulna Component
07613327138474Ulna Component
07613327138467Ulna Component
07613327138450Ulna Component
07613327138412Ulna Component

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