00-5842-023-10

GUDID 00889024193987

Zimmer, Inc.

Unicondylar knee insert

• Primary Device ID: 00889024193987
• NIH Device Record Key: 3b634edd-9584-4d72-983b-5d7fee140395
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5842-23-10
• Catalog Number: 00-5842-023-10
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024193987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033363

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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: 2019-12-10
• Device Publish Date: 2015-09-24

Devices Manufactured by Zimmer, Inc.

• 00887868575457 - Z1™ Hip System: 2024-09-17
• 00887868575464 - Z1™ Hip System: 2024-09-17
• 00887868575471 - Z1™ Hip System: 2024-09-17
• 00887868575488 - Z1™ Hip System: 2024-09-17
• 00887868575495 - Z1™ Hip System: 2024-09-17
• 00887868575501 - Z1™ Hip System: 2024-09-17
• 00887868575518 - Z1™ Hip System: 2024-09-17
• 00887868575525 - Z1™ Hip System: 2024-09-17