Comprehensive Segmental Revision System SSI002476

GUDID 00880304848863

Biomet Orthopedics, LLC

Humeral body prosthesis trial

• Primary Device ID: 00880304848863
• NIH Device Record Key: 6357642a-e6af-4d06-ad5d-12aff544b58a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive Segmental Revision System
• Version Model Number: SSI002476
• Catalog Number: SSI002476
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

• Height: 52 Millimeter
• Height: 52 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304848863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111746

FDA Product Code

• MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

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

[00880304848863]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-30

On-Brand Devices [Comprehensive Segmental Revision System]

• 00880304848870: SSI002477
• 00880304848863: SSI002476
• 00880304848856: SSI002475