ARCOS MODULAR REVISION SYSTEM 31-302021

GUDID 00880304506206

Biomet Orthopedics, LLC

Femoral stem prosthesis trial
Primary Device ID00880304506206
NIH Device Record Key6fecfd03-a786-4b65-9754-7f917f4727fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameARCOS MODULAR REVISION SYSTEM
Version Model Number31-302021
Catalog Number31-302021
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
GS100880304506206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304506206]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-30
Device Publish Date2016-10-21

On-Brand Devices [ARCOS MODULAR REVISION SYSTEM]

00880304676084CALCAR BODY TRIAL - BASIC, SIZE A 50MM +0 STANDARD OFFSET
0088030467602231-311357
0088030467601531-311356
0088030467595731-311347
0088030467594031-311346
0088030467588931-311337
0088030467587231-311336
0088030467581031-311327
0088030467580331-311326
0088030467574231-311317
0088030467573531-311316
0088030467567431-311307
0088030467566731-311306
00880304675582CALCAR BODY TRIAL - BASIC, SIZE A 50MM +0 HIGH OFFSET
00880304675568110018394
00880304675551110018393
00880304675544110018392
00880304675537110018391
00880304675520110018390
00880304675513110018389
00880304675506110018388
0088030460778131-301804
0088030460777431-301803
0088030460776731-301802
0088030450827931-302024
0088030450755531-302026
0088030450624431-301327
0088030450622031-301357
0088030450621331-301356
0088030450620631-302021
0088030450501831-301623
0088030450500131-301834
0088030450498131-301336
0088030450497431-301316
0088030450496731-301526
0088030450495031-301726
0088030450493631-301337
0088030450492931-302023
0088030450491231-301835
0088030450489931-301621
0088030450488231-301626
0088030450487531-301525
0088030450486831-301521
0088030450484431-301723
0088030450483731-301886
0088030450482031-301836
0088030450481331-301832
0088030450480631-301721
0088030450479031-301887
0088030450478331-301625

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