FREEDOM HIP SYSTEM 11-107016

GUDID 00880304203433

Biomet Orthopedics, LLC

Metallic femoral head prosthesis
Primary Device ID00880304203433
NIH Device Record Key0e19dc35-7fb4-4e10-b112-e69cf6e752ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREEDOM HIP SYSTEM
Version Model Number11-107016
Catalog Number11-107016
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
GS100880304203433 [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 [FREEDOM HIP SYSTEM]

00880304687530110025134
00880304687523110025133
00880304687516110025132
00880304687509110025131
00880304687493110025130
00880304687486110025129
00880304687479110025128
00880304687462110025127
00880304687455110025126
0088030443260414-107017
0088030443253614-107019
0088030443252914-107018
0088030443251214-107021
0088030443250514-107016
0088030443249914-107020
0088030420349511-107021
0088030420348811-107020
0088030420347111-107019
0088030420346411-107018
0088030420345711-107017
0088030420343311-107016

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