PAR 5 HAP HIP SYSTEM 21-109268

GUDID 00880304282162

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00880304282162
• NIH Device Record Key: ff423ef3-233e-40ee-90fc-6361e8f2e91b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAR 5 HAP HIP SYSTEM
• Version Model Number: 21-109268
• Catalog Number: 21-109268
• 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	00880304282162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022094

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [PAR 5 HAP HIP SYSTEM]

• 00880304282179: 21-109272
• 00880304282162: 21-109268
• 00880304282155: 21-109264
• 00880304282148: 21-109260
• 00880304282131: 21-109256