JUGGERKNOT LONG 916035

GUDID 00880304543386

Biomet Orthopedics, LLC

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00880304543386
• NIH Device Record Key: b39cb620-cfcd-4e91-9678-e64cc9bec2e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUGGERKNOT LONG
• Version Model Number: 916035
• Catalog Number: 916035
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304543386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110145

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

Sterilization

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

[00880304543386]

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: 2017-07-28

On-Brand Devices [JUGGERKNOT LONG]

• 00880304928435: 110016992
• 00880304566477: 110002759
• 00880304564077: 916040
• 00880304564060: 916039
• 00880304564053: 916038
• 00880304564046: 916034
• 00880304564039: 916020
• 00880304543584: 916036
• 00880304543577: 916037
• 00880304543386: 916035