00-5842-022-08

GUDID 00889024633582

Zimmer, Inc.

Unicondylar knee insert

• Primary Device ID: 00889024633582
• NIH Device Record Key: af0427bb-a4c4-40f6-b4db-bed3a4c93b89
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5842-22-08
• Catalog Number: 00-5842-022-08
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Height: 8 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024633582 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-07
• Device Publish Date: 2022-02-25

Devices Manufactured by Zimmer, Inc.

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• 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