HALLEY ALL-POLY HIP SYSTEM 163257

GUDID 00880304255548

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00880304255548
• NIH Device Record Key: 1040393f-da5b-4570-b86a-af6ea8f5ca83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALLEY ALL-POLY HIP SYSTEM
• Version Model Number: 163257
• Catalog Number: 163257
• 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	00880304255548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960984

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 [HALLEY ALL-POLY HIP SYSTEM]

• 00880304255593: 163262
• 00880304255586: 163261
• 00880304255579: 163260
• 00880304255555: 163258
• 00880304255548: 163257
• 00880304255531: 163256
• 00880304255524: 163255
• 00880304255517: 163254
• 00880304255500: 163253
• 00880304255494: 163252
• 00880304255487: 163251