PAR 5 HIP SYSTEM 109220

GUDID 00880304197282

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular

• Primary Device ID: 00880304197282
• NIH Device Record Key: 19f07a86-942b-492a-a2f9-f6135f86cc7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAR 5 HIP SYSTEM
• Version Model Number: 109220
• Catalog Number: 109220
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304197282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000254

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 HIP SYSTEM]

• 00880304197404: 109272
• 00880304197381: 109268
• 00880304197374: 109264
• 00880304197350: 109260
• 00880304197343: 109256
• 00880304197282: 109220