MALLORY/HEAD REVISION HIP SYSTEM 104815

GUDID 00880304189928

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis
Primary Device ID00880304189928
NIH Device Record Key2bec2de1-f2de-40ea-9c4b-15a34dc5edad
Commercial Distribution StatusIn Commercial Distribution
Brand NameMALLORY/HEAD REVISION HIP SYSTEM
Version Model Number104815
Catalog Number104815
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
GS100880304189928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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 [MALLORY/HEAD REVISION HIP SYSTEM]

00880304441750104917
00880304189942104817
00880304189935104816
00880304189928104815
00880304189904104814
00880304189881104813
00880304189850104811
00880304189836104810
00880304189812104809
00880304005334104812
05019279343263104915
05019279343256104914
05019279343249104913
05019279343232104912
05019279343225104911
05019279343218104910

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