GUDID 00889024380424

Zimmer, Inc.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 00889024380424
• NIH Device Record Key: 923e6de2-feb7-448d-b576-9f7da51d5996
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 32-8105-38
• 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@zimmer.com

Device Dimensions

• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024274082 [Primary]
GS1	00889024380424 [Package]; Contains: 00889024274082; Package: [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040389

FDA Product Code

• JDB: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, 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: 5
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-08-09

Devices Manufactured by Zimmer, Inc.

• 00889024691315 - Identity Humeral: 2025-09-30
• 00889024691353 - Identity Humeral: 2025-09-30
• 00889024691476 - Identity Humeral: 2025-09-30
• 00889024691551 - Identity Humeral: 2025-09-30
• 00889024691582 - Identity Humeral: 2025-09-30
• 00889024691681 - Identity Humeral: 2025-09-30
• 00889024691728 - Identity Humeral: 2025-09-30
• 00889024691919 - Identity Humeral: 2025-09-30