AFFIXUS®HIP FRACTURE NAIL ANTI-ROTATION SCREW 814501080

GUDID 00887868038716

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00887868038716
• NIH Device Record Key: 7247ec32-10d2-4646-b26b-bdc9222a32ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFIXUS®HIP FRACTURE NAIL ANTI-ROTATION SCREW
• Version Model Number: 8145-01-080
• Catalog Number: 814501080
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868038716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100238

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND 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: 2015-10-24

On-Brand Devices [AFFIXUS®HIP FRACTURE NAIL ANTI-ROTATION SCREW]

• 00887868038778: 8145-01-110
• 00887868038761: 8145-01-105
• 00887868038754: 8145-01-100
• 00887868038747: 8145-01-095
• 00887868038730: 8145-01-090
• 00887868038723: 8145-01-085
• 00887868038716: 8145-01-080
• 00887868038709: 8145-01-075
• 00887868038693: 8145-01-070
• 00887868038686: 8145-01-065
• 00887868038679: 8145-01-060
• 00887868038662: 8145-01-055
• 00887868038655: 8145-01-050