VANGUARD COMPLETE KNEE SYSTEM 195570

GUDID 00880304558748

Biomet Orthopedics, LLC

Uncoated knee tibia/insert prosthesis
Primary Device ID00880304558748
NIH Device Record Key1ad555d0-8cee-4474-b88e-11bea9b3e9ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD COMPLETE KNEE SYSTEM
Version Model Number195570
Catalog Number195570
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304558748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [VANGUARD COMPLETE KNEE SYSTEM]

00880304989948SSI003228
00880304989931SSI003227
00880304989924SSI003226
00880304989917SSI003225
00880304989900SSI003224
00880304989894SSI003223
00880304865716SSI002373
00880304865709SSI002372
00880304865693SSI002359
00880304865686SSI002358
00880304865679SSI002357
00880304865662SSI002356
00880304865655SSI002347
00880304865648SSI002346
00880304865631SSI002345
00880304856332SSI001058
00880304856325SSI001057
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00880304560727195948
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00880304560550195931
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00880304560444195920

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