IMPACT RIMLOC HIP SYSTEM 12-112028

GUDID 00880304221093

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00880304221093
• NIH Device Record Key: 03afd8a7-9dcb-41d0-88d3-519cbf5768f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPACT RIMLOC HIP SYSTEM
• Version Model Number: 12-112028
• Catalog Number: 12-112028
• 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	00880304221093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

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 [IMPACT RIMLOC HIP SYSTEM]

• 00880304221093: 12-112028
• 00880304221086: 12-112027
• 00880304221079: 12-112026
• 00880304221062: 12-112025
• 00880304221055: 12-112024
• 00880304221048: 12-112023
• 00880304221031: 12-112022