HEAT LOOP 905414

GUDID 00880304406612

Biomet Orthopedics, LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00880304406612
• NIH Device Record Key: 1c571648-1a98-4c89-8373-55bb6ec014e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEAT LOOP
• Version Model Number: 905414
• Catalog Number: 905414
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304406612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945765

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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: 2016-09-22

On-Brand Devices [HEAT LOOP]

• 00880304406612: 905414
• 00880304377448: 450026