MEDALLION MODULAR HIP SYSTEM 71-001452

GUDID 00880304639966

Biomet Orthopedics, LLC

Uncoated hip femur prosthesis, modular
Primary Device ID00880304639966
NIH Device Record Key8f483eff-c2d7-4f55-89c5-9088fe6eb258
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDALLION MODULAR HIP SYSTEM
Version Model Number71-001452
Catalog Number71-001452
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
GS100880304639966 [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 [MEDALLION MODULAR HIP SYSTEM]

0088030464018471-007015
0088030464017771-007014
0088030464016071-007013
0088030464015371-007012
0088030464014671-007011
0088030464013971-007010
0088030464012271-007009
0088030464011571-007008
0088030464010871-007007
0088030464009271-007006
0088030464008571-007005
0088030464007871-007004
0088030464006171-007003
0088030464005471-007002
0088030464004771-007001
0088030464003071-003502
0088030464002371-003452
0088030464001671-003402
0088030464000971-002502
0088030463999771-002452
0088030463998071-002402
0088030463997371-001502
0088030463996671-001452
0088030463995971-001402
0088030463994271-000502
0088030463993571-000452
0088030463992871-000402
0088030463991171-000400
0088030463990471-000399
0088030463989871-000396
0088030463988171-000395

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