Ultra-Drive® 423874

GUDID 00887868523731

Biomet Orthopedics, LLC

Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip Hard-tissue ultrasonic surgical system handpiece tip

• Primary Device ID: 00887868523731
• NIH Device Record Key: 6e6dec33-320c-4f7a-b7e1-8e713fa7cd2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-Drive®
• Version Model Number: 423874
• Catalog Number: 423874
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868523731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031280

FDA Product Code

• JXE: DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-29
• Device Publish Date: 2021-11-21

On-Brand Devices [Ultra-Drive®]

• 00880304372924: 423834
• 00880304372917: 423833
• 00887868523731: 423874