COMPREHENSIVE SRS SEAS HEAD TRIAL 405193

GUDID 00880304542433

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00880304542433
• NIH Device Record Key: bc3ad3a6-f777-46db-8f79-8244b035e5c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE SRS SEAS HEAD TRIAL
• Version Model Number: 405193
• Catalog Number: 405193
• 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: true
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304542433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111746

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00880304542433]

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: 2016-10-27

On-Brand Devices [COMPREHENSIVE SRS SEAS HEAD TRIAL]

• 00880304542440: 405194
• 00880304542433: 405193
• 00880304542389: 405192
• 00880304542327: 405142