RIM-LOC HIP SYSTEM 11-105215

GUDID 00880304201040

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304201040
NIH Device Record Key58facec0-41a3-438d-ad51-f67d122199a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIM-LOC HIP SYSTEM
Version Model Number11-105215
Catalog Number11-105215
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
GS100880304201040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

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 [RIM-LOC HIP SYSTEM]

0088030420112511-105236
0088030420111811-105234
0088030420108811-105223
0088030420107111-105218
0088030420106411-105217
0088030420105711-105216
0088030420104011-105215
0088030420103311-105214
0088030420102611-105213
0088030420101911-105212
0088030420100211-105208
0088030420099911-105207
0088030420098211-105206
0088030420097511-105205
0088030420096811-105204
0088030420095111-105203
0088030420094411-105202
0088030420093711-105201
00880304191693105428
00880304191686105427
00880304191679105426
00880304191662105425
00880304191655105424
00880304191648105423
00880304191631105422
00880304191624105421
00880304191617105420

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