INTEGRAL HIP SYSTEM 11-162676

GUDID 00880304208636

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304208636
NIH Device Record Keyb111bd73-1dce-4cc2-81d1-5a42da02740b
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRAL HIP SYSTEM
Version Model Number11-162676
Catalog Number11-162676
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
GS100880304208636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

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 HIP SYSTEM]

0088030420864311-162678
0088030420863611-162676
0088030420862911-162674
0088030420861211-162672
0088030420858211-162619
0088030420856811-162615
0088030420855111-162613
0088030420854411-162611
0088030420853711-162609

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