MAX VPCK-WIRE 231209095

GUDID 00880304804654

Biomet Orthopedics, LLC

Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: 00880304804654
• NIH Device Record Key: 24add3b8-3b95-4c87-8279-436512488cea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAX VPCK-WIRE
• Version Model Number: 231209095
• Catalog Number: 231209095
• 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: 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304804654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160058

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00880304804654]

Moist Heat or Steam Sterilization

[00880304804654]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-27

On-Brand Devices [MAX VPCK-WIRE]

• 00880304805026: 231214127
• 00880304804821: 231211105
• 00880304804654: 231209095