Minima S Instrument Set 9045.03.202

GUDID 08033390084987

Trial Modular Neck #2

LIMACORPORATE SPA

Femoral stem prosthesis trial

• Primary Device ID: 08033390084987
• NIH Device Record Key: 2f1d82ab-f771-4678-86c0-38122f7f0453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minima S Instrument Set
• Version Model Number: Trial Modular Neck
• Catalog Number: 9045.03.202
• 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	08033390084987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141327

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

[08033390084987]

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: 2016-06-17

On-Brand Devices [Minima S Instrument Set]

• 08033390084987: Trial Modular Neck #2
• 08033390084970: Trial Modular Neck #1
• 08033051091569: Trial Modular Neck #1 Lat.
• 08033390179317: Trial Modular Neck #1 Lat.
• 08033390153973: Trial Modular Neck #12
• 08033390153966: Trial Modular Neck #11
• 08033390153959: Trial Modular Neck #10
• 08033390153942: Trial Modular Neck #9
• 08033390153935: Trial Modular Neck #8
• 08033390153928: Trial Modular Neck #7