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 ID: 04026575224081
• NIH Device Record Key: df6416be-19c6-4807-b9d0-fcda3e4b9428
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Model Standard Knee Prosthesis System SL
• Version Model Number: 16-2855/32
• Catalog Number: 16-2855/32
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575224081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151008

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-23
• Device Publish Date: 2021-08-13

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

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