PHYSICA CR 9065.13.590

GUDID 08033390088336

#9-Left-Trial Femoral Component

LIMACORPORATE SPA

Knee femur prosthesis trial, reusable
Primary Device ID08033390088336
NIH Device Record Key8067db83-3fcb-43a9-95a6-79bb186eb888
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHYSICA CR
Version Model NumberTrial Femoral Component
Catalog Number9065.13.590
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390088336 [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

[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


[08033390088336]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2022-03-22
Device Publish Date2016-05-14

On-Brand Devices [PHYSICA CR]

08033390087490CR Femoral components Right #10
08033390087483CR Femoral components Right #9
08033390087476CR Femoral components Right #8
08033390087469CR Femoral components Right #7
08033390087452CR Femoral components Right #6
08033390087445CR Femoral components Right #5
08033390087438CR Femoral components Right #4
08033390087421CR Femoral components Right #3
08033390087414CR Femoral components Right #2
08033390087407CR Femoral components Right #1
08033390087605CR Femoral Component Left #10
08033390087599CR Femoral Component Left #9
08033390087582CR Femoral Component Left #8
08033390087575CR Femoral Component Left #7
08033390087568CR Femoral Component Left #6
08033390087551CR Femoral Component Left #5
08033390087544CR Femoral Component Left #4
08033390087537CR Femoral Component Left #3
08033390087520CR Femoral Component Left #2
08033390087513CR Femoral Component Left #1
08033390088343#10-Left-Trial Femoral Component
08033390088336#9-Left-Trial Femoral Component
08033390088329#8-Left-Trial Femoral Component
08033390088312#7-Left-Trial Femoral Component
08033390088305#6-Left-Trial Femoral Component
08033390088299#5-Left-Trial Femoral Component
08033390088282#4-Left-Trial Femoral Component
08033390088275#3-Left-Trial Femoral Component
08033390088268#2-Left-Trial Femoral Component
08033390088251#1-Left-Trial Femoral Component
08033390088244#10-Right-Trial Femoral Component
08033390088237#9-Right-Trial Femoral Component
08033390088220#8-Right-Trial Femoral Component
08033390088213#7-Right-Trial Femoral Component
08033390088206#6-Right-Trial Femoral Component
08033390088190#5-Right-Trial Femoral Component
08033390088183#4-Right-Trial Femoral Component
08033390088176#3-Right-Trial Femoral Component
08033390088169#2-Right-Trial Femoral Component
08033390088152#1-Right-Trial Femoral Component

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