SELEX® MODULAR HEAD TRIAL S003136

GUDID 00880304163416

Biomet Orthopedics, LLC

Femoral head prosthesis trial

• Primary Device ID: 00880304163416
• NIH Device Record Key: 6e3da4b5-84e3-47e9-8ee8-ee468eb414ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELEX® MODULAR HEAD TRIAL
• Version Model Number: S003136
• Catalog Number: S003136
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304163416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062997

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[00880304163416]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-23

On-Brand Devices [SELEX® MODULAR HEAD TRIAL]

• 00880304171633: S993136
• 00880304168503: S663136
• 00880304163706: S123136
• 00880304163539: S063136
• 00880304163522: S033136
• 00880304163416: S003136
• 00880304165526: S333136