K Knee 9069.10.285

GUDID 08033390066228

Long Pins for Trial Tibial Plates - PHYSICA & MULTIGEN PLUS

LIMACORPORATE SPA

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID08033390066228
NIH Device Record Keya61263a9-9ca4-4ba6-9f64-68c903f6b5b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameK Knee
Version Model NumberLong Pins for Trial Tibial Plates
Catalog Number9069.10.285
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390066228 [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

[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


[08033390066228]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-05
Device Publish Date2016-08-05

On-Brand Devices [K Knee]

08033390066228Long Pins for Trial Tibial Plates - PHYSICA & MULTIGEN PLUS
08033390026819Pins for Trial Tibial Plates - PHYSICA & MULTIGEN PLUS

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