VANGUARD COMPLETE KNEE SYSTEM 195291

GUDID 00880304556898

Biomet Orthopedics, LLC

Coated knee tibia prosthesis
Primary Device ID00880304556898
NIH Device Record Keyb613a7a1-6fbf-434e-96fa-b6d7ddedabff
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD COMPLETE KNEE SYSTEM
Version Model Number195291
Catalog Number195291
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100880304556898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-24
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
00880304560765195952
00880304560758195951
00880304560741195950
00880304560734195949
00880304560727195948
00880304560710195947
00880304560703195946
00880304560697195945
00880304560680195944
00880304560673195943
00880304560666195942
00880304560659195941
00880304560642195940
00880304560635195939
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00880304560611195937
00880304560604195936
00880304560598195935
00880304560581195934
00880304560574195933
00880304560567195932
00880304560550195931
00880304560543195930
00880304560536195929
00880304560529195928
00880304560512195927
00880304560505195926
00880304560499195925
00880304560482195924
00880304560475195923
00880304560468195922
00880304560451195921
00880304560444195920

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