BIOMET SERIES A STANDARD PATELLA TRIAL 32-484702

GUDID 00880304437937

Biomet Orthopedics, LLC

Patella prosthesis trial
Primary Device ID00880304437937
NIH Device Record Key8011f475-196c-4bc4-9759-e21c1b536769
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMET SERIES A STANDARD PATELLA TRIAL
Version Model Number32-484702
Catalog Number32-484702
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 Datetrue
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(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100880304437937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


[00880304437937]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-10-25

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