BIO-MODULAR / BI-POLAR SHOULDER 113143

GUDID 00880304003958

Biomet Orthopedics, LLC

Bipolar partial shoulder prosthesis

• Primary Device ID: 00880304003958
• NIH Device Record Key: beda8f55-b245-4bbe-8e96-dc74f1c64aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-MODULAR / BI-POLAR SHOULDER
• Version Model Number: 113143
• Catalog Number: 113143
• 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	00880304003958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030710

FDA Product Code

• MJT: PROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED

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 [BIO-MODULAR / BI-POLAR SHOULDER]

• 00880304212411: 113147
• 00880304212398: 113144
• 00880304007802: 113145
• 00880304003958: 113143
• 00880304002388: 113146