BI-ANGULAR SYSTEM 114072

GUDID 00880304001275

Biomet Orthopedics, LLC

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00880304001275
• NIH Device Record Key: bab74260-8e95-422e-9555-c56691ddf6ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-ANGULAR SYSTEM
• Version Model Number: 114072
• Catalog Number: 114072
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304001275 [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 SYSTEM]

• 00880304215122: 114094
• 00880304215016: 114063
• 00880304214996: 114061
• 00880304214903: 114052
• 00880304214897: 114029
• 00880304214880: 114028
• 00880304214873: 114027
• 00880304214866: 114026
• 00880304214859: 114025
• 00880304214842: 114023
• 00880304009622: 114022
• 00880304007055: 114054
• 00880304006966: 114053
• 00880304003927: 114090
• 00880304003910: 114092
• 00880304003453: 114073
• 00880304002531: 114024
• 00880304001329: 114071
• 00880304001275: 114072