Omni™ Surgical Suite AI1019

GUDID 00889024624887

ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Medical image management system

• Primary Device ID: 00889024624887
• NIH Device Record Key: 06a74d0e-1965-45e0-a779-fd98e831d9ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni™ Surgical Suite
• Version Model Number: AI1019
• Catalog Number: AI1019
• Company DUNS: 137354267
• Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024624887 [Primary]

FDA Product Code

• OUG: Medical device data system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-25
• Device Publish Date: 2022-05-17

Devices Manufactured by ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

• 00889024616325 - Stablecut®: 2024-04-17
• 00889024616332 - Stablecut®: 2024-04-17
• 00889024626447 - A.T.S.® Personalized Pressure®: 2023-09-07
• 00889024647497 - Stablecut®: 2023-03-03
• 00889024647503 - Stablecut®: 2023-03-03
• 00889024647510 - Stablecut®: 2023-03-03
• 00889024647527 - Stablecut®: 2023-03-03
• 00889024647534 - Stablecut®: 2023-03-03