MALLORY/HEAD PRIMARY HIP SYSTEM 11-104112

GUDID 00880304199002

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304199002
NIH Device Record Keyd286b558-7159-4540-9615-ef05909c6ed0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMALLORY/HEAD PRIMARY HIP SYSTEM
Version Model Number11-104112
Catalog Number11-104112
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
GS100880304199002 [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 [MALLORY/HEAD PRIMARY HIP SYSTEM]

0088030428237721-124317
0088030428236021-124316
0088030428235321-124315
0088030428234621-124314
0088030428233921-124313
0088030428232221-124312
0088030428231521-124311
0088030428230821-124310
0088030428229221-124309
0088030428181321-104119
0088030428180621-104118
0088030428179021-104117
0088030428178321-104116
0088030428177621-104115
0088030428176921-104114
0088030428175221-104113
0088030428174521-104112
0088030428173821-104111
0088030428172121-104110
0088030428171421-104109
0088030419947711-104214
0088030419915611-104119
0088030419914911-104118
0088030419913211-104117
0088030419911811-104116
0088030419909511-104115
0088030419906411-104114
0088030419903311-104113
0088030419900211-104112
0088030419897511-104111
0088030419895111-104110
0088030419892011-104109
0088030419889011-104108
0088030419886911-104107
0088030419885211-104106
0088030401034511-104208
0088030401033811-104217
0088030401028411-104216
0088030401025311-104209
0088030401022211-104211
0088030400957811-104212
0088030400589111-104213
0088030400133611-104215
0088030400072811-104210

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