Vanguard 360® Instrument 32-488471

GUDID 00887868497094

Biomet Orthopedics, LLC

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Primary Device ID00887868497094
NIH Device Record Key1cdae3fe-8edf-4bb0-b86d-c0d21df74feb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVanguard 360® Instrument
Version Model Number32-488471
Catalog Number32-488471
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

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 Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868497094 [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

[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


[00887868497094]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-26

On-Brand Devices [Vanguard 360® Instrument]

0088786849712432-488474
0088786849711732-488473
0088786849710032-488472
0088786849709432-488471
0088786849708732-488470
0088786849707032-488428
0088786849654732-487559

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