ECHO BI-METRIC 110025095

GUDID 00880304698123

Biomet Orthopedics, LLC

Femoral stem prosthesis trial
Primary Device ID00880304698123
NIH Device Record Key65383662-3b08-45cd-9a8a-833fb82c5a67
Commercial Distribution StatusIn Commercial Distribution
Brand NameECHO BI-METRIC
Version Model Number110025095
Catalog Number110025095
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 Datetrue
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 Identifiers

Device Issuing AgencyDevice ID
GS100880304698123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304698123]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2017-07-28

On-Brand Devices [ECHO BI-METRIC]

00880304698567110026867
00880304698482110025764
00880304698185110025098
00880304698178110025102
00880304698161110025101
00880304698154110025093
00880304698147110025090
00880304698130110025099
00880304698123110025095
00880304698116110025094
00880304698109110025087
00880304698093110025097
00880304698086110025091
00880304698079110025092
00880304698062110025089
00880304467538595613
00880304467514595610

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