Endo-Model Standard Knee Prosthesis System SL 16-2855/32

GUDID 04026575224081

Distal Femoral Replacement Components

WALDEMAR LINK GmbH & Co. KG

Uncoated knee femur prosthesis, metallic
Primary Device ID04026575224081
NIH Device Record Keydf6416be-19c6-4807-b9d0-fcda3e4b9428
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-Model Standard Knee Prosthesis System SL
Version Model Number16-2855/32
Catalog Number16-2855/32
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
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 Batchfalse
Serial Numbertrue
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
GS104026575224081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-23
Device Publish Date2021-08-13

On-Brand Devices [Endo-Model Standard Knee Prosthesis System SL]

04026575224463Femoral Segmets, full
04026575224456Femoral Segmets, full
04026575224449Femoral Segmets, full
04026575224432Femoral Segmets, full
04026575224425Femoral Segmets, full
04026575224418Femoral Segmets, full
04026575224401Femoral Segmets, full
04026575224395Femoral Segmets, full
04026575224388Femoral Segmets, full
04026575224371Femoral Segmets, full
04026575224364Femoral Segmets, full
04026575224357Femoral Segmets, full
04026575224340Femoral Segmets
04026575224333Femoral Segmets
04026575224302Femoral Segmets
04026575224296Femoral Segmets
04026575224258Femoral Segmets
04026575224241Femoral Segmets
04026575224227Femoral Segmets
04026575224210Femoral Segmets
04026575224197Femoral Segmets
04026575224180Femoral Segmets
04026575224173Femoral Segmets
04026575224111Femoral Segmets
04026575224104Distal Femoral Replacement Components
04026575224098Distal Femoral Replacement Components
04026575224081Distal Femoral Replacement Components
04026575223718Distal Femoral Replacement Components
04026575223701Distal Femoral Replacement Components
04026575223695Distal Femoral Replacement Components

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