VANGUARD 360 32-360692

GUDID 00880304523197

Biomet Orthopedics, LLC

Knee femur prosthesis trial
Primary Device ID00880304523197
NIH Device Record Keyd9b5f3fd-4e1a-4f1c-8314-a5dd9adbc74d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD 360
Version Model Number32-360692
Catalog Number32-360692
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
GS100880304523197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBVProsthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


[00880304523197]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-29
Device Publish Date2016-09-22

On-Brand Devices [VANGUARD 360]

0088030455033932-360143
0088030455032232-360144
0088030453100032-360460
0088030453096632-360468
0088030452381432-360759
0088030452380732-360758
0088030452378432-360757
0088030452335732-360796
0088030452334032-360790
0088030452333332-360766
0088030452332632-360800
0088030452331932-360902
0088030452319732-360692
0088030452316632-360278
0088030452315932-360826
0088030452314232-360818
0088030452313532-360784
0088030452312832-360768
0088030452311132-360830
0088030452310432-360806
0088030452309832-360828
0088030452308132-360802
0088030452307432-360820
0088030452306732-360822
0088030452305032-360824
0088030452304332-360814
0088030452303632-360798
0088030452302932-360810
0088030452300532-360794
0088030452299232-360778
0088030452298532-360812
0088030452297832-360804
0088030452296132-360808
0088030452295432-360816
0088030452293032-360786
0088030452292332-360788
0088030452291632-360840
0088030452289332-360903
0088030452288632-360901
0088030452287932-360792
0088030452286232-360782
0088030452285532-360772
0088030452284832-360760
0088030452282432-360219
0088030452280032-360770
0088030452279432-360762
0088030452278732-360764
0088030452277032-360776
0088030452276332-360774
0088030452275632-360780

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