BI-ANGULAR SHOULDER SYSTEM 114064

GUDID 00880304215023

Biomet Orthopedics, LLC

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00880304215023
• NIH Device Record Key: aa4d3fb8-118d-43d9-8dc4-9b00f5e62f13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-ANGULAR SHOULDER SYSTEM
• Version Model Number: 114064
• Catalog Number: 114064
• 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	00880304215023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032895

FDA Product Code

• MBF: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [BI-ANGULAR SHOULDER SYSTEM]

• 00880304376915: 434446
• 00880304376885: 434443
• 00880304215030: 114065
• 00880304215023: 114064
• 00880304003934: 114068
• 00880304003767: 114066
• 00880304003484: 114069
• 00880304002739: 114067
• 00880304000322: 114070