00-5842-025-11

GUDID 00889024194113

Zimmer, Inc.

Unicondylar knee insert

• Primary Device ID: 00889024194113
• NIH Device Record Key: 12edd7e4-f5a2-49a5-94dc-9ccdf352bfd7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5842-25-11
• Catalog Number: 00-5842-025-11
• 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

• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024194113 [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

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• 00889024678767 - OsseoFit™ Stemless Shoulder: 2024-12-26
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• 00889024678781 - OsseoFit™ Stemless Shoulder: 2024-12-26
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• 00889024678804 - OsseoFit™ Stemless Shoulder: 2024-12-26