00-8011-020-16

GUDID 00889024432987

Zimmer, Inc.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 00889024432987
• NIH Device Record Key: d6ac57e9-aa62-4b20-aaf2-1b733e5937ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8011-20-16
• Catalog Number: 00-8011-020-16
• 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: true
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024432987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001733

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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: 2020-01-14
• Device Publish Date: 2016-05-24

Devices Manufactured by Zimmer, Inc.

• 00887868139741 - Affixus®: 2025-04-07
• 00887868139758 - Affixus®: 2025-04-07
• 00887868139765 - Affixus®: 2025-04-07
• 00887868139772 - Affixus®: 2025-04-07
• 00887868139789 - Affixus®: 2025-04-07
• 00887868139796 - Affixus®: 2025-04-07
• 00887868139802 - Affixus®: 2025-04-07
• 00887868139819 - Affixus®: 2025-04-07