BI-METRIC REVISION HIP SYSTEM 162354

GUDID 00880304252196

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis
Primary Device ID00880304252196
NIH Device Record Key2c28d025-6103-4dc8-92e7-c9acabf72159
Commercial Distribution StatusIn Commercial Distribution
Brand NameBI-METRIC REVISION HIP SYSTEM
Version Model Number162354
Catalog Number162354
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
GS100880304252196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

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-METRIC REVISION HIP SYSTEM]

00880304252288162369
00880304252271162368
00880304252264162361
00880304252257162360
00880304252240162359
00880304252233162357
00880304252226162356
00880304252202162355
00880304252196162354
00880304252103162340
00880304010758162350
00880304010741162351
00880304010734162358
00880304009912162344
00880304007819162353
00880304007161162364
00880304007017162349
00880304007000162348
00880304006997162343
00880304006980162366
00880304005686162346
00880304005679162347
00880304003798162367
00880304003521162365
00880304003514162363
00880304003507162362
00880304001138162341
00880304000278162352
00880304000261162342
00880304000254162345

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