INTEGRAL 180 HIP SYSTEM 11-166012

GUDID 00880304209985

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular
Primary Device ID00880304209985
NIH Device Record Keya54220fe-b407-4390-bb9e-b0a7c6d554c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRAL 180 HIP SYSTEM
Version Model Number11-166012
Catalog Number11-166012
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
GS100880304209985 [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 [INTEGRAL 180 HIP SYSTEM]

00880304257870166019
00880304257863166018
00880304257856166016
00880304257849166015
00880304257832166014
00880304257801166012
00880304257788166010
0088030421006611-166019
0088030421005911-166018
0088030421004211-166017
0088030421003511-166016
0088030421001111-166015
0088030421000411-166014
0088030420999211-166013
0088030420998511-166012
0088030420997811-166011
00880304010321166013
00880304010307166017
00880304010291166011

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