Endo II 31-401164

GUDID 00887868479380

Biomet Orthopedics, LLC

Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial
Primary Device ID00887868479380
NIH Device Record Key27e1fa87-5dff-4a7a-878c-20f93128f03c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo II
Version Model Number31-401164
Catalog Number31-401164
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868479380 [Primary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


[00887868479380]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-08

On-Brand Devices [Endo II]

0088786847939731-401165
0088786847938031-401164
0088786847937331-401163
0088786847936631-401162
0088786847935931-401161

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