SCREW SYSTEM 113845

GUDID 00880304213951

Biomet Orthopedics, LLC

Orthopaedic cement spacer

• Primary Device ID: 00880304213951
• NIH Device Record Key: 401d3a47-753b-44a6-82a7-3de89f3e6c0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCREW SYSTEM
• Version Model Number: 113845
• Catalog Number: 113845
• 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	00880304213951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030710

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-18
• Device Publish Date: 2015-10-24

On-Brand Devices [SCREW SYSTEM]

• 00880304214095: 113862
• 00880304214088: 113861
• 00880304213999: 113848
• 00880304213982: 113847
• 00880304213975: 113846
• 00880304213951: 113845
• 00880304213937: 113844
• 00880304213920: 113843