BIO-MODULAR SHOULDER SYSTEM 113923

GUDID 00880304214415

Biomet Orthopedics, LLC

Stem-fixed humeral head prosthesis
Primary Device ID00880304214415
NIH Device Record Key287efedc-07a2-4eae-9045-573a72209f5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO-MODULAR SHOULDER SYSTEM
Version Model Number113923
Catalog Number113923
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
GS100880304214415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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 [BIO-MODULAR SHOULDER SYSTEM]

00880304658899CP550457
00880304554276113945
00880304554269113944
00880304554252113943
00880304554245113942
00880304554238113941
00880304554221113940
00880304443044113863
00880304434127113865
0088030443368711-113730
0088030443367011-113724
0088030443366311-113727
0088030443365611-113726
0088030443364911-113725
0088030443363211-113729
0088030443362511-113728
0088030443361811-113720
0088030443360111-113731
0088030443359511-113723
00880304433496113867
00880304214569113938
00880304214552113937
00880304214545113936
00880304214538113935
00880304214521113934
00880304214514113933
00880304214507113932
00880304214491113931
00880304214484113930
00880304214477113929
00880304214460113928
00880304214453113927
00880304214446113926
00880304214439113925
00880304214422113924
00880304214415113923
00880304214392113922
00880304214378113921
00880304214224113896
00880304214217113894
00880304214200113892
00880304214194113890
00880304214187113888
00880304214163113886
00880304214156113884
00880304214149113882
00880304214132113880
00880304214125113874
00880304214101113872
00880304214057113854

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