MULTIGEN PLUS Knee Instrument Set 9066.40.025

GUDID 08033390036146

Patellar Drilling Guide

LIMACORPORATE SPA

Surgical drill guide, reusable

• Primary Device ID: 08033390036146
• NIH Device Record Key: 9170d83c-90b2-42c6-bcb8-9887ccae00a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTIGEN PLUS Knee Instrument Set
• Version Model Number: Patellar Drilling Guide
• Catalog Number: 9066.40.025
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390036146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141934

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

[08033390036146]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• 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