MULTIGEN PLUS Knee Instrument Set 9066.40.128

GUDID 08033390036191

Trial Patellar Dome-Dia.=28mm h8mm

LIMACORPORATE SPA

Patella prosthesis trial

• Primary Device ID: 08033390036191
• NIH Device Record Key: b1cf58ca-386c-4626-a543-df563ae56ee6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTIGEN PLUS Knee Instrument Set
• Version Model Number: Trial Patellar Dome
• Catalog Number: 9066.40.128
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390036191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141934

FDA Product Code

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

Sterilization

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

[08033390036191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-07-05
• Device Publish Date: 2016-07-27

On-Brand Devices [MULTIGEN PLUS Knee Instrument Set]

• 08033390036207: Trial Patellar Dome-Dia.=32mm h8mm
• 08033390036191: Trial Patellar Dome-Dia.=28mm h8mm
• 08033390036153: Trial Patellar Dome-Dia.=32mm h10mm
• 08033390036146: Patellar Drilling Guide
• 08033390036184: Patellar Mask