INTEGRAL REVISION HIP SYSTEM 166021

GUDID 00880304000353

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304000353
NIH Device Record Key8f66624d-feda-4c54-b212-fffe91f9cd3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRAL REVISION HIP SYSTEM
Version Model Number166021
Catalog Number166021
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
GS100880304000353 [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 [INTEGRAL REVISION HIP SYSTEM]

00880304258051166049
00880304258044166048
00880304258037166047
00880304258020166046
00880304258013166044
00880304258006166043
00880304257986166042
00880304257979166041
00880304257962166029
00880304257955166028
00880304257948166027
00880304257931166026
00880304257924166024
00880304257900166023
00880304257894166022
00880304007444166045
00880304000360166025
00880304000353166021

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