REFOBACIN® BONE CEMENT R 110034358

GUDID 00880304990227

BIOMET

Orthopaedic cement, medicated

• Primary Device ID: 00880304990227
• NIH Device Record Key: 75f0c12f-7c11-4098-b4f6-879e1249bb2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFOBACIN® BONE CEMENT R
• Version Model Number: 110034358
• Catalog Number: 110034358
• Company DUNS: 260930126
• Company Name: BIOMET
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: +0330475759100
• Email: eufrvra@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304990227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171540

FDA Product Code

• MBB: BONE CEMENT, ANTIBIOTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-30

On-Brand Devices [REFOBACIN® BONE CEMENT R]

• 00880304990227: 110034358
• 00880304990210: 110034357
• 00880304990203: 110034356
• 00880304990197: 110034355