ORTHOPEDIC SALVAGE SYSTEM (OSS) 161094

GUDID 00880304467989

Biomet Orthopedics, LLC

Tibial insert
Primary Device ID00880304467989
NIH Device Record Keyc142999f-0884-4e4e-b623-3d3b7429f19d
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOPEDIC SALVAGE SYSTEM (OSS)
Version Model Number161094
Catalog Number161094
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
GS100880304467989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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 [ORTHOPEDIC SALVAGE SYSTEM (OSS)]

00880304928527CP114840
00880304927476CP114851
00880304817708150477
00880304703438CP114850
00880304703421CP114849
00880304703414CP114848
00880304703407CP114847
00880304703391CP114846
00880304703384CP114844
00880304703377CP114843
00880304703360CP114842
00880304703353CP114841
00880304703346CP114839
00880304703339CP114838
00880304703322CP114837
00880304703315CP114836
00880304703308CP114835
00880304703292CP114834
00880304703285CP114833
00880304703278CP114832
00880304674998151847
00880304674981151846
00880304674974151845
00880304674967151844
00880304674950151843
00880304674943151842
00880304674936151841
00880304674929151840
00880304674912151839
00880304674905151838
00880304674899151837
00880304674882151836
00880304674660151830
00880304674653151829
00880304674646151828
00880304674639151827
00880304674622151826
00880304674615151825
00880304674608151824
00880304674592151856
00880304674585151860
00880304674578151859
00880304674561151858
00880304674554151857
00880304674547151855
00880304674530151851
00880304674523151850
00880304674516151849
00880304674509151848
00880304674493151854

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