DISCOVERY-MOSAIC ELBOW SYSTEM 114894

GUDID 00880304215719

Biomet Orthopedics, LLC

Uncoated elbow humerus prosthesis

• Primary Device ID: 00880304215719
• NIH Device Record Key: f73f3602-960f-4834-b92d-a9083bffc205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISCOVERY-MOSAIC ELBOW SYSTEM
• Version Model Number: 114894
• Catalog Number: 114894
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304215719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020045

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-17
• Device Publish Date: 2015-10-24

On-Brand Devices [DISCOVERY-MOSAIC ELBOW SYSTEM]

• 00880304215726: 114895
• 00880304215719: 114894
• 00880304215702: 114893
• 00880304215696: 114892
• 00880304215689: 114891
• 00880304215672: 114890