Proven Gen-Flex PS Knee System

GUDID 10840843108498

Modular PS Femur, Left

Stelkast Incorporated

Uncoated knee femur prosthesis, metallic
Primary Device ID10840843108498
NIH Device Record Keyba60f043-0405-441a-a883-2eaa2cebebe5
Commercial Distribution Discontinuation2018-01-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameProven Gen-Flex PS Knee System
Version Model NumberSC2955-3
Company DUNS804792265
Company NameStelkast Incorporated
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110840843108498 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-11
Device Publish Date2015-08-05

On-Brand Devices [Proven Gen-Flex PS Knee System]

10840843108610Modular PS Femur, Right
10840843108603Modular PS Femur, Right
10840843108597Modular PS Femur, Right
10840843108580Modular PS Femur, Right
10840843108573Modular PS Femur, Right
10840843108566Modular PS Femur, Right
10840843108559Modular PS Femur, Right
10840843108542Modular PS Femur, Right
10840843108535Modular PS Femur, Left
10840843108528Modular PS Femur, Left
10840843108511Modular PS Femur, Left
10840843108504Modular PS Femur, Left
10840843108498Modular PS Femur, Left
10840843108481Modular PS Femur, Left
10840843108474Modular PS Femur, Left
10840843108467Modular PS Femur, Left
10840843108450SC2954-6
10840843108443SC2954-5
10840843108436SC2954-4
10840843108429SC2954-3.5
10840843108412SC2954-3
10840843108405SC2954-2.5
10840843108399SC2954-2
10840843108382SC2954-1
10840843108375SC2953-6
10840843108368SC2953-5
10840843108351SC2953-4
10840843108344SC2953-3.5
10840843108337SC2953-3
10840843108320SC2953-2.5
10840843108313SC2953-2
10840843108306SC2953-1
10840843101598SC1584-6T6F
10840843101581SC1584-6T5F
10840843101574SC1584-5T6F
10840843101567SC1584-5T5F
10840843101550SC1584-5T4F
10840843101543SC1584-4T5F
10840843101536SC1584-4T4F
10840843101529SC1584-4T3F
10840843101512SC1584-3T4F
10840843101505SC1584-3T3F
10840843101499SC1584-3T2F
10840843101482SC1584-2T3F
10840843101475SC1584-2T2F
10840843101468SC1584-2T1F
10840843101451SC1584-1T2F
10840843101444SC1584-1T1F
10840843101437SC1581-6
10840843101420SC1581-5

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