ABSOLUTE BI-POLAR SHOULDER SYSTEM 113153

GUDID 00880304003446

Biomet Orthopedics, LLC

Bipolar partial shoulder prosthesis

• Primary Device ID: 00880304003446
• NIH Device Record Key: 3905d448-1de5-43a3-9d4c-68684922fb4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABSOLUTE BI-POLAR SHOULDER SYSTEM
• Version Model Number: 113153
• Catalog Number: 113153
• 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	00880304003446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002998

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 [ABSOLUTE BI-POLAR SHOULDER SYSTEM]

• 00880304212466: 113165
• 00880304212459: 113162
• 00880304005242: 113169
• 00880304003897: 113159
• 00880304003446: 113153
• 00880304002715: 113150
• 00880304002371: 113156