ECHO BI-METRIC HIP SYSTEM 192521

GUDID 00880304512122

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis
Primary Device ID00880304512122
NIH Device Record Key01e30d66-e0d9-4c20-ba7a-c23a58274ac7
Commercial Distribution StatusIn Commercial Distribution
Brand NameECHO BI-METRIC HIP SYSTEM
Version Model Number192521
Catalog Number192521
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
GS100880304512122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, hip, hemi-, femoral, metal

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 [ECHO BI-METRIC HIP SYSTEM]

00880304512122192521
00880304512115192520
00880304512108192519
00880304512092192421
00880304512085192420
00880304512078192419
00880304512061192418
00880304505964192518
00880304492264192121
00880304492257192120
00880304492240192021
00880304492226192020
00880304463431192411
00880304463424192013
00880304463417192417
00880304463400192112
00880304463394192016
00880304463387192118
00880304463370192414
00880304463363192515
00880304463356192517
00880304463349192110
00880304463332192416
00880304463325192109
00880304463318192009
00880304463295192111
00880304463271192408
00880304463264192119
00880304463257192115
00880304463240192108
00880304463233192107
00880304463226192015
00880304463196192011
00880304463165192415
00880304463158192014
00880304463141192008
00880304463134192510
00880304463127192513
00880304463110192012
00880304463103192010
00880304463080192017
00880304463073192409
00880304463066192007
00880304463035192019
00880304463011192512
00880304463004192410
00880304462991192413
00880304462984192412
00880304462946192516
00880304462939192018

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.