PATELLA TRIAL 32-467365

GUDID 00880304339415

Biomet Orthopedics, LLC

Patella prosthesis trial
Primary Device ID00880304339415
NIH Device Record Key2401c2e3-f1bc-47be-a4be-00499b285fe1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePATELLA TRIAL
Version Model Number32-467365
Catalog Number32-467365
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 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(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
GS100880304339415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


[00880304339415]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-22

On-Brand Devices [PATELLA TRIAL]

0088030433941532-467365
0088030433940832-467364
0088030433939232-467363
0088030433938532-467362

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