SAIPH 193-026

GUDID 05055455506084

SAIPH Femur Cemented Yellow Right Size 2

MATORTHO LTD

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 05055455506084
• NIH Device Record Key: 0a83f3e5-400f-47cc-b640-3f844ed7fcd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAIPH
• Version Model Number: 193-026
• Catalog Number: 193-026
• Company DUNS: 216819863
• Company Name: MATORTHO LTD
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	05055455506084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140222

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-05-06

On-Brand Devices [SAIPH]

• 05055455509788: SAIPH Cemented Patella 42mm
• 05055455509771: SAIPH Cemented Patella 38mm
• 05055455509764: SAIPH Cemented Patella 34mm
• 05055455509351: SAIPH Cemented Patella 30mm
• 05055455509344: SAIPH Cemented Patella 26mm
• 05055455509337: SAIPH Cemented Patella 23mm
• 05055455507401: SAIPH Fixed Tibial Bearing Green Right Size F 20mm
• 05055455507395: SAIPH Fixed Tibial Bearing Green Right Size F 18mm
• 05055455507388: SAIPH Fixed Tibial Bearing Green Right Size F 16mm
• 05055455507371: SAIPH Fixed Tibial Bearing Green Right Size F 14mm
• 05055455507364: SAIPH Fixed Tibial Bearing Green Right Size F 12mm
• 05055455507357: SAIPH Fixed Tibial Bearing Green Right Size F 10mm
• 05055455507340: SAIPH Fixed Tibial Bearing Green Left Size F 20mm
• 05055455507333: SAIPH Fixed Tibial Bearing Green Left Size F 18mm
• 05055455507326: SAIPH Fixed Tibial Bearing Green Left Size F 16mm
• 05055455507319: SAIPH Fixed Tibial Bearing Green Left Size F 14mm
• 05055455507302: SAIPH Fixed Tibial Bearing Green Left Size F 12mm
• 05055455507296: SAIPH Fixed Tibial Bearing Green Left Size F 10mm
• 05055455507289: SAIPH Fixed Tibial Bearing Green Right Size E 20mm
• 05055455507272: SAIPH Fixed Tibial Bearing Green Right Size E 18mm
• 05055455507265: SAIPH Fixed Tibial Bearing Green Right Size E 16mm
• 05055455507258: SAIPH Fixed Tibial Bearing Green Right Size E 14mm
• 05055455507241: SAIPH Fixed Tibial Bearing Green Right Size E 12mm
• 05055455507234: SAIPH Fixed Tibial Bearing Green Right Size E 10mm
• 05055455507227: SAIPH Fixed Tibial Bearing Green Left Size E 20mm
• 05055455507210: SAIPH Fixed Tibial Bearing Green Left Size E 18mm
• 05055455507203: SAIPH Fixed Tibial Bearing Green Left Size E 16mm
• 05055455507197: SAIPH Fixed Tibial Bearing Green Left Size E 14mm
• 05055455507180: SAIPH Fixed Tibial Bearing Green Left Size E 12mm
• 05055455507173: SAIPH Fixed Tibial Bearing Green Left Size E 10mm
• 05055455507166: SAIPH Fixed Tibial Bearing Blue Right Size E 20mm
• 05055455507159: SAIPH Fixed Tibial Bearing Blue Right Size E 18mm
• 05055455507142: SAIPH Fixed Tibial Bearing Blue Right Size E 16mm
• 05055455507135: SAIPH Fixed Tibial Bearing Blue Right Size E 14mm
• 05055455507128: SAIPH Fixed Tibial Bearing Blue Right Size E 12mm
• 05055455507111: SAIPH Fixed Tibial Bearing Blue Right Size E 10mm
• 05055455507104: SAIPH Fixed Tibial Bearing Blue Left Size E 20mm
• 05055455507098: SAIPH Fixed Tibial Bearing Blue Left Size E 18mm
• 05055455507081: SAIPH Fixed Tibial Bearing Blue Left Size E 16mm
• 05055455507074: SAIPH Fixed Tibial Bearing Blue Left Size E 14mm
• 05055455507067: SAIPH Fixed Tibial Bearing Blue Left Size E 12mm
• 05055455507050: SAIPH Fixed Tibial Bearing Blue Left Size E 10mm
• 05055455507043: SAIPH Fixed Tibial Bearing Blue Right Size D 20mm
• 05055455507036: SAIPH Fixed Tibial Bearing Blue Right Size D 18mm
• 05055455507029: SAIPH Fixed Tibial Bearing Blue Right Size D 16mm
• 05055455507012: SAIPH Fixed Tibial Bearing Blue Right Size D 14mm
• 05055455507005: SAIPH Fixed Tibial Bearing Blue Right Size D 12mm
• 05055455506992: SAIPH Fixed Tibial Bearing Blue Right Size D 10mm
• 05055455506985: SAIPH Fixed Tibial Bearing Blue Left Size D 20mm
• 05055455506978: SAIPH Fixed Tibial Bearing Blue Left Size D 18mm