VANGUARD 360 INSTRUMENT 32-360652

GUDID 00880304495791

Biomet Orthopedics, LLC

Knee femur prosthesis trial
Primary Device ID00880304495791
NIH Device Record Keyc1cd9230-70e8-4375-a132-2561a13913c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD 360 INSTRUMENT
Version Model Number32-360652
Catalog Number32-360652
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304495791 [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

[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

Moist Heat or Steam Sterilization


[00880304495791]

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 [VANGUARD 360 INSTRUMENT]

0088030467793732-360894
0088030467792032-360893
0088030467791332-360892
0088030467790632-360891
0088030467789032-360890
0088030467788332-360889
0088030467787632-360888
0088030467786932-360887
0088030467785232-360886
0088030467784532-360885
0088030467783832-360884
0088030467782132-360883
0088030467781432-360882
0088030467780732-360881
00880304677791REAMER 10MM
0088030467262832-360028
0088030467261132-360035
0088030467257432-360033
0088030467256732-360027
0088030467255032-360026
0088030467254332-360034
0088030467253632-360025
0088030467252932-360024
0088030467251232-360023
0088030467250532-360022
0088030467249932-360021
0088030454608032-360645
0088030454607332-360677
0088030454606632-360691
0088030453712532-360653
0088030453711832-360643
0088030453710132-360639
0088030453709532-360667
0088030453708832-360647
0088030453707132-360655
0088030453706432-360631
0088030453705732-360627
0088030453704032-360681
0088030453703332-360683
0088030453694432-360663
0088030453690632-360679
0088030453688332-360661
0088030453681432-360637
0088030453680732-360671
0088030453679132-360669
0088030453678432-360629
0088030453677732-360635
0088030453676032-360665
0088030453675332-360685
0088030453188832-360613

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