VANGUARD INSTRUMENT 32-360592

GUDID 00880304516250

Biomet Orthopedics, LLC

Knee tibia prosthesis trial
Primary Device ID00880304516250
NIH Device Record Key4d556780-e837-48ef-8f35-8881b8edc95c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD INSTRUMENT
Version Model Number32-360592
Catalog Number32-360592
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
GS100880304516250 [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

[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

Moist Heat or Steam Sterilization


[00880304516250]

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 INSTRUMENT]

0088030452281732-486131
0088030451627432-360522
0088030451626732-360594
0088030451625032-360592
0088030451612032-360542
0088030451611332-360546
0088030451610632-360540
0088030451609032-360526
0088030451603832-360586
0088030451602132-360580
0088030451601432-360550
0088030451600732-360548
0088030451599432-360560
0088030451598732-360530
0088030451586432-360544
0088030451585732-360528
0088030451584032-360520
0088030451583332-360570
0088030451582632-360568
0088030451581932-360588
0088030451580232-360584
0088030451579632-360590
0088030451578932-360552
0088030451577232-360574
0088030451575832-360532
0088030451574132-360524
0088030451573432-360572
0088030451572732-360534
0088030451571032-360554
0088030451570332-360562
0088030451569732-360566
0088030451568032-360582
0088030451566632-360564
0088030450194232-486254
0088030449607132-360299
0088030434999532-486255

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