RINGLOC TRI-POLAR HIP SYSTEM 11-165201

GUDID 00880304209602

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304209602
NIH Device Record Keye19dca23-1019-4a9a-9452-900c77de8a61
Commercial Distribution StatusIn Commercial Distribution
Brand NameRINGLOC TRI-POLAR HIP SYSTEM
Version Model Number11-165201
Catalog Number11-165201
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
GS100880304209602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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 [RINGLOC TRI-POLAR HIP SYSTEM]

0088030420963311-165204
0088030420962611-165203
0088030420961911-165202
0088030420960211-165201
0088030420958911-165200
0088030420957211-165144
0088030420956511-165143
0088030420955811-165142
0088030420954111-165141
0088030420953411-165140
0088030420952711-165124
0088030420951011-165123
0088030420950311-165122
0088030420949711-165121
0088030420947311-165120
0088030420946611-165115
0088030420945911-165114
0088030420944211-165113
0088030420943511-165112
0088030420942811-165111
0088030420941111-165110
0088030420940411-165104
0088030420939811-165103
0088030420938111-165102
0088030420937411-165101
0088030420936711-165100

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