ARCOS MODULAR REVISION HIP SYSTEM 11-302135

GUDID 00880304494008

Biomet Orthopedics, LLC

Uncoated hip femur prosthesis, modular
Primary Device ID00880304494008
NIH Device Record Key5f7c3a3d-6bc6-4567-8346-8287512ac19b
Commercial Distribution StatusIn Commercial Distribution
Brand NameARCOS MODULAR REVISION HIP SYSTEM
Version Model Number11-302135
Catalog Number11-302135
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
GS100880304494008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

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 [ARCOS MODULAR REVISION HIP SYSTEM]

0088030453925911-302109
0088030451396911-301621
0088030451181111-300921
0088030449507411-301819
0088030449409111-302153
0088030449408411-302151
0088030449407711-302149
0088030449406011-302147
0088030449405311-302145
0088030449404611-302143
0088030449403911-302141
0088030449402211-302139
0088030449401511-302137
0088030449400811-302135
0088030449399511-302133
0088030449398811-302131
0088030449397111-302129
0088030449396411-302127
0088030449395711-302125
0088030449394011-301030
0088030449393311-301029
0088030449392611-301028
0088030449391911-301027
0088030449390211-301026
0088030449389611-301025
0088030449388911-301023
0088030449387211-301021
0088030449386511-300930
0088030449385811-300929
0088030449384111-300928
0088030449383411-300927
0088030449382711-300926
0088030449381011-300925
0088030449380311-300923
0088030449379711-300830
0088030449378011-300829
0088030449377311-300828
0088030449376611-300827
0088030449375911-300826
0088030449374211-300825
0088030449373511-300823
0088030449372811-300821
0088030449371111-302026
0088030449370411-302025
0088030449369811-302023
0088030449368111-302021
0088030449367411-302019
0088030449366711-302017
0088030449365011-301926
0088030449364311-301925

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