ECHO® BI-METRIC HIP SYSTEM 110025750

GUDID 00880304698444

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304698444
• NIH Device Record Key: c99f3e33-e8e6-4518-8781-17b453f91abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHO® BI-METRIC HIP SYSTEM
• Version Model Number: 110025750
• Catalog Number: 110025750
• 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	00880304698444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143009

FDA Product Code

• LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

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

[00880304698444]

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 [ECHO® BI-METRIC HIP SYSTEM]

• 00880304698451: 110025751
• 00880304698444: 110025750
• 00880304698437: 110025749
• 00880304698420: 110025754
• 00880304698413: 110025753
• 00880304698406: 110025752