MULTIGEN PLUS Knee Instrument Set 9066.40.128

GUDID 08033390036191

Trial Patellar Dome-Dia.=28mm h8mm

LIMACORPORATE SPA

Patella prosthesis trial
Primary Device ID08033390036191
NIH Device Record Keyb1cf58ca-386c-4626-a543-df563ae56ee6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMULTIGEN PLUS Knee Instrument Set
Version Model NumberTrial Patellar Dome
Catalog Number9066.40.128
Company DUNS432066322
Company NameLIMACORPORATE SPA
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390036191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390036191]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-07-05
Device Publish Date2016-07-27

On-Brand Devices [MULTIGEN PLUS Knee Instrument Set]

08033390036207Trial Patellar Dome-Dia.=32mm h8mm
08033390036191Trial Patellar Dome-Dia.=28mm h8mm
08033390036153Trial Patellar Dome-Dia.=32mm h10mm
08033390036146Patellar Drilling Guide
08033390036184Patellar Mask

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