89-8507-405-00

GUDID 00889024354616

Zimmer Surgical SA

Coagulation factor XII inhibitor IVD, control

• Primary Device ID: 00889024354616
• NIH Device Record Key: 44294a18-e8b4-492d-b639-0167de97ea28
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 89-8507-405-00
• Catalog Number: 89-8507-405-00
• Company DUNS: 481290781
• Company Name: Zimmer Surgical SA
• 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: false
• 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@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024354616 [Primary]

FDA Product Code

• HAB: Saw, Powered, And Accessories

Sterilization

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

[00889024354616]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-16

Devices Manufactured by Zimmer Surgical SA

• 00887868572890 - Zimmer Biomet®: 2023-10-06
• 00887868572906 - Zimmer Biomet®: 2023-10-06
• 00887868572913 - Zimmer Biomet®: 2023-10-06
• 00889024521100 - Zimmer Biomet™: 2023-10-04
• 00889024581760 - Zimmer Biomet™: 2023-10-04
• 00889024355163 - Zimmer Biomet™: 2022-06-21
• 00889024490109 - Zimmer Biomet™: 2022-06-21
• 00889024521292 - Zimmer Biomet™ X Series Power System: 2021-11-01