ECHO BI-METRIC MICROPLASTY HIP STEM 110025577

GUDID 00880304698239

Biomet Orthopedics, LLC

Femoral stem prosthesis trial
Primary Device ID00880304698239
NIH Device Record Key810eadd2-e09f-4059-9a49-247ec9cc0a45
Commercial Distribution StatusIn Commercial Distribution
Brand NameECHO BI-METRIC MICROPLASTY HIP STEM
Version Model Number110025577
Catalog Number110025577
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 Datefalse
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
GS100880304698239 [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

[00880304698239]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-12-19

On-Brand Devices [ECHO BI-METRIC MICROPLASTY HIP STEM]

00880304698703XR193108-4
00880304698697XR193108-3
00880304698680XR193108-2
00880304698673XR193108-1
00880304698666XR193107-4
00880304698659XR193107-3
00880304698642XR193107-2
00880304698635XR193107-1
00880304698628XR192907-4
00880304698611XR192907-3
00880304698604XR192907-2
00880304698598XR192907-1
00880304698390110025757
00880304698383110025756
00880304698376110025755
00880304698369110025760
00880304698352110025759
00880304698345110025758
00880304698338110025587
00880304698321110025586
00880304698314110025585
00880304698307110025584
00880304698291110025583
00880304698284110025582
00880304698277110025581
00880304698260110025580
00880304698253110025579
00880304698246110025578
00880304698239110025577
00880304698222110025576
00880304698215110025575
00880304698208110025574
00880304698055110025100
00880304698048110025088

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