4404-22-040

GUDID 00889024169753

Zimmer, Inc.

Femoral head bipolar component

• Primary Device ID: 00889024169753
• NIH Device Record Key: 8df7253d-81d1-49c1-acea-29b040dfe555
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4404-22-040
• Catalog Number: 4404-22-040
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024169753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833404

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or 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: 2015-10-24

Devices Manufactured by Zimmer, Inc.

• 00889024625839 - Zimmer Biomet® Freedom® Head: 2024-11-15
• 00889024625846 - Zimmer Biomet®: 2024-11-15
• 00887868585654 - Zimmer Biomet® 12/14 Spherical Head Trials: 2024-11-13
• 00889024630192 - Persona® Knee System: 2024-11-13
• 00889024630208 - Persona® Knee System: 2024-11-13
• 00889024630215 - Persona® Knee System: 2024-11-13
• 00889024630222 - Persona® Knee System: 2024-11-13
• 00889024630239 - Persona® Knee System: 2024-11-13