PHYSICA MIS 9065.10.A51

GUDID 08033390133678

Femoral A/P Sizing Stylus

LIMACORPORATE SPA

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID08033390133678
NIH Device Record Key943e9b01-a424-4253-97fd-40216f4b7db8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHYSICA MIS
Version Model NumberFemoral Sizing Stylus
Catalog Number9065.10.A51
Company DUNS432066322
Company NameLIMACORPORATE SPA
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 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 Identifiers

Device Issuing AgencyDevice ID
GS108033390133678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


[08033390133678]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-08-05
Device Publish Date2018-01-19

On-Brand Devices [PHYSICA MIS]

08033390133715Tibial Cutting Block 3° Left
08033390133708Tibial Cutting Block 0° Left
08033390133692Tibial Cutting Block 3° Right
08033390133685Tibial Cutting Block 0° Right
08033390133678Femoral A/P Sizing Stylus
08033390133661Femoral A/P Sizer

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