INTEGRAL CENTRALIZER HIP SYSTEM 11-162709

GUDID 00880304208667

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece
Primary Device ID00880304208667
NIH Device Record Keyb28dc107-b8a2-4546-be96-8d6b0d449206
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRAL CENTRALIZER HIP SYSTEM
Version Model Number11-162709
Catalog Number11-162709
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
GS100880304208667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDGProsthesis, hip, femoral component, cemented, metal

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 CENTRALIZER HIP SYSTEM]

0088030422335612-162617
0088030422333212-162615
0088030422331812-162613
0088030422329512-162611
0088030422327112-162609
0088030420872811-162717
0088030420871111-162715
0088030420868111-162711
0088030420866711-162709
0088030400112111-162713

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