00-5850-050-20

GUDID 00889024700536

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024700536
• NIH Device Record Key: 7e6f6d35-7044-4166-8aed-d067fa6f5bf0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 00-5850-050-20
• Catalog Number: 00-5850-050-20
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024700536 [Primary]

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, 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: 2025-09-15
• Device Publish Date: 2025-09-05

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