4365-28-079

GUDID 00889024167940

Zimmer, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00889024167940
• NIH Device Record Key: ce103442-6a16-4e7a-9b64-9dff8b570efb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4365-28-079
• Catalog Number: 4365-28-079
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024167940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955033

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

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: 2020-01-14
• Device Publish Date: 2017-10-23

Devices Manufactured by Zimmer, Inc.

• 00887868585661 - Zimmer Biomet® 12/14 Spherical Head Trials: 2024-11-19
• 00887868139628 - Affixus®: 2024-11-18
• 00887868139635 - Affixus®: 2024-11-18
• 00887868139642 - Affixus®: 2024-11-18
• 00887868139659 - Affixus®: 2024-11-18
• 00887868139666 - Affixus®: 2024-11-18
• 00887868139673 - Affixus®: 2024-11-18
• 00887868139680 - Affixus®: 2024-11-18