GENERATION 4 HIP SYSTEM 162786

GUDID 00880304253582

Biomet Orthopedics, LLC

Orthopaedic cement spacer

• Primary Device ID: 00880304253582
• NIH Device Record Key: 79603ad1-b2f7-4e81-a731-3b08a05f078a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENERATION 4 HIP SYSTEM
• Version Model Number: 162786
• Catalog Number: 162786
• 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	00880304253582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031734

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-22
• Device Publish Date: 2015-10-24

On-Brand Devices [GENERATION 4 HIP SYSTEM]

• 00880304591332: 11-165017
• 00880304591325: 11-165015
• 00880304591318: 11-165013
• 00880304591301: 11-165011
• 00880304591295: 11-165009
• 00880304554764: 165017
• 00880304554757: 165015
• 00880304521858: 165013
• 00880304497405: 165009
• 00880304457577: 165011
• 00880304253599: 162787
• 00880304253582: 162786
• 00880304253568: 162784
• 00880304253544: 162782
• 00880304253537: 162781