Repicci II Resurfacing Knee System CP112349

GUDID 00880304652729

Biomet Sports Medicine, LLC

Tibial insert
Primary Device ID00880304652729
NIH Device Record Key28c5e74c-2944-4aaf-9ed7-2037a749eb72
Commercial Distribution StatusIn Commercial Distribution
Brand NameRepicci II Resurfacing Knee System
Version Model NumberCP112349
Catalog NumberCP112349
Company DUNS627100159
Company NameBiomet Sports Medicine, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-348-9500
Emailcustomerservice@biomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304652729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 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 Date2016-08-03

On-Brand Devices [Repicci II Resurfacing Knee System]

00880304652781CP112355
00880304652767CP112353
00880304652743CP112351
00880304652736CP112350
00880304652729CP112349

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