Ultra-Drive® Tool 423868

GUDID 00887868523694

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: 00887868523694
• NIH Device Record Key: 81c23aba-5749-4ec9-ad04-64d5123e2a89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-Drive® Tool
• Version Model Number: 423868
• Catalog Number: 423868
• 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	00887868523694 [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® Tool]

• 00887868523847: 423926
• 00887868523830: 423925
• 00887868523823: 423924
• 00887868523816: 423923
• 00887868523809: 423922
• 00887868523793: 423921
• 00887868523786: 423894
• 00887868523779: 423883
• 00887868523762: 423881
• 00887868523755: 423880
• 00887868523748: 423876
• 00887868523724: 423873
• 00887868523717: 423872
• 00887868523700: 423871
• 00887868523694: 423868
• 00887868523687: 423864
• 00887868523670: 423859
• 00887868560958: 423892
• 00887868560941: 423890
• 00887868560927: 423842
• 00887868560910: 423840
• 00887868560903: 423830
• 00887868560897: 423828
• 00887868560880: 423826