MALLORY-HEAD ACETABULAR SHELL 11-104164

GUDID 05019279347414

Biomet Uk Ltd

Acetabular shell
Primary Device ID05019279347414
NIH Device Record Keybcfcd403-beac-4c2c-ad4f-b3700eeed52b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMALLORY-HEAD ACETABULAR SHELL
Version Model Number11-104164
Catalog Number11-104164
Company DUNS219322575
Company NameBiomet Uk Ltd
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.c
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105019279347414 [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 Date2016-03-25

On-Brand Devices [MALLORY-HEAD ACETABULAR SHELL]

0501927934742111-104166
0501927934741411-104164
0501927934739111-104160

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