BALANCE MICROPLASTY HIP SYSTEM 180214

GUDID 00880304446366

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304446366
NIH Device Record Key51ce056e-7fa9-4ddf-8f9f-dec47c89911d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBALANCE MICROPLASTY HIP SYSTEM
Version Model Number180214
Catalog Number180214
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
GS100880304446366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 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 [BALANCE MICROPLASTY HIP SYSTEM]

00880304455474180218
00880304455467180224
00880304455450180217
00880304455443180227
00880304455436180223
00880304455429180219
00880304455412180222
00880304455405180220
00880304455399180226
00880304455382180216
00880304455375180221
00880304455368180225
00880304446489180207
00880304446472180215
00880304446465180212
00880304446458180209
00880304446441180205
00880304446434180213
00880304446427180202
00880304446410180206
00880304446403180203
00880304446397180210
00880304446380180211
00880304446373180200
00880304446366180214
00880304446359180201
00880304446342180204
00880304446335180208

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