JUGGERKNOT FLEX DRILL BIT 912046

GUDID 00880304563988

Biomet Orthopedics, LLC

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00880304563988
• NIH Device Record Key: 16bcd034-549e-4279-8e90-928ecbe28835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUGGERKNOT FLEX DRILL BIT
• Version Model Number: 912046
• Catalog Number: 912046
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304563988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110145

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-04

On-Brand Devices [JUGGERKNOT FLEX DRILL BIT]

• 00880304563988: 912046
• 00880304563971: 912045
• 00880304516564: 912037