GENERATION 4 HIP SYSTEM 11-165011

GUDID 00880304591301

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece
Primary Device ID00880304591301
NIH Device Record Key9fbe319c-b796-47a4-a9a4-8dfcb72c03c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENERATION 4 HIP SYSTEM
Version Model Number11-165011
Catalog Number11-165011
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
GS100880304591301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

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 [GENERATION 4 HIP SYSTEM]

0088030459133211-165017
0088030459132511-165015
0088030459131811-165013
0088030459130111-165011
0088030459129511-165009
00880304554764165017
00880304554757165015
00880304521858165013
00880304497405165009
00880304457577165011
00880304253599162787
00880304253582162786
00880304253568162784
00880304253544162782
00880304253537162781

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