LOCKING CANCELLOUS SCREW 815355034

GUDID 00887868041716

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868041716
• NIH Device Record Key: b8ab6cf9-169c-494f-8030-2e0d0de41d07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOCKING CANCELLOUS SCREW
• Version Model Number: 8153-55-034
• Catalog Number: 815355034
• 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	00887868041716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060969

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00887868041716]

Moist Heat or Steam Sterilization

[00887868041716]

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: 2015-10-24

On-Brand Devices [LOCKING CANCELLOUS SCREW]

• 00887868077449: 815355014
• 00887868041808: 8153-55-048
• 00887868041792: 8153-55-046
• 00887868041778: 8153-55-044
• 00887868041761: 8153-55-042
• 00887868041747: 8153-55-038
• 00887868041730: 8153-55-036
• 00887868041716: 8153-55-034
• 00887868041709: 8153-55-032
• 00887868041686: 8153-55-028
• 00887868041679: 8153-55-026
• 00887868041655: 8153-55-024
• 00887868041648: 8153-55-022
• 00887868041631: 8153-55-020
• 00887868041624: 8153-55-018
• 00887868041617: 8153-55-016