BALANCE HIP SYSTEM 180012

GUDID 00880304268623

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304268623
NIH Device Record Keye0638285-f1da-48d0-8ae0-d714d92ffed0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBALANCE HIP SYSTEM
Version Model Number180012
Catalog Number180012
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
GS100880304268623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-22
Device Publish Date2015-10-24

On-Brand Devices [BALANCE HIP SYSTEM]

00880304268739180023
00880304268722180022
00880304268715180021
00880304268708180020
00880304268692180019
00880304268685180018
00880304268678180017
00880304268661180016
00880304268654180015
00880304268647180014
00880304268630180013
00880304268623180012
00880304268616180011
00880304268609180010
00880304268593180009
00880304268586180008
00880304268579180007
00880304268562180006
00880304268555180005
00880304268548180004
00880304268531180003
00880304268524180002
00880304268517180001
00880304268500180000
00880304258761170099
00880304258754170098
00880304258747170097
00880304258730170096

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