BI-ANGULAR SYSTEM 114022

GUDID 00880304009622

Biomet Orthopedics, LLC

Stem-fixed humeral head prosthesis
Primary Device ID00880304009622
NIH Device Record Key6d3e1faa-5e2b-4958-82a4-4b747bbd9697
Commercial Distribution StatusIn Commercial Distribution
Brand NameBI-ANGULAR SYSTEM
Version Model Number114022
Catalog Number114022
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
GS100880304009622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

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 [BI-ANGULAR SYSTEM]

00880304215122114094
00880304215016114063
00880304214996114061
00880304214903114052
00880304214897114029
00880304214880114028
00880304214873114027
00880304214866114026
00880304214859114025
00880304214842114023
00880304009622114022
00880304007055114054
00880304006966114053
00880304003927114090
00880304003910114092
00880304003453114073
00880304002531114024
00880304001329114071
00880304001275114072

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