Comprehensive Segmental Revision System (SRS) SSI004181

GUDID 00887868228155

Biomet Orthopedics, LLC

Humeral body prosthesis trial

• Primary Device ID: 00887868228155
• NIH Device Record Key: f0a084e1-5ddf-4878-af84-d70df8441e02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive Segmental Revision System (SRS)
• Version Model Number: SSI004181
• Catalog Number: SSI004181
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868228155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111746

FDA Product Code

• JDC: Prosthesis, Elbow, Constrained, Cemented

Sterilization

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

[00887868228155]

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: 2017-11-03

On-Brand Devices [Comprehensive Segmental Revision System (SRS)]

• 00887868228162: SSI004182
• 00887868228155: SSI004181
• 00887868228148: SSI004180