Mimix QS

GUDID 00841036020828

BIOMET MICROFIXATION, INC

Orthopaedic cement, non-medicated

• Primary Device ID: 00841036020828
• NIH Device Record Key: 352ab442-6c62-4d02-ae56-1a27c8271efa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mimix QS
• Version Model Number: 02-1110
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• 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

Customer Support Contacts

• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036020828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023718

FDA Product Code

• GXP: Methyl Methacrylate For Cranioplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-11

On-Brand Devices [Mimix QS]

• 00841036020828: 02-1110
• 00841036020811: 02-1105