00-5842-082-10

GUDID 00889024194656

Zimmer, Inc.

Uncoated unicondylar knee tibia prosthesis, polyethylene

• Primary Device ID: 00889024194656
• NIH Device Record Key: ef4943ed-45b6-4b00-a90d-01cb5d4881ac
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5842-82-10
• Catalog Number: 00-5842-082-10
• 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

• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024194656 [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.

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• 00889024691766 - PSN TASP PROV BTM R GH +3MM: 2025-05-26
• 00889024691773 - PSN TASP PROV BTM L J +3MM: 2025-05-26
• 00889024691780 - PSN TASP PROV BTM R J +3MM: 2025-05-26
• 00889024691797 - PSN TASP PROV BTM L GH +3MM: 2025-05-26
• 00889024691803 - PSN TASP PROV BTM L CD +3MM: 2025-05-26
• 00889024691810 - PSN TASP PROV BTM R EF +3MM: 2025-05-26
• 00889024691827 - PSN TASP PROV BTM L EF +3MM: 2025-05-26