MCS 146-01-54

GUDID 10885862027627

Exactech, Inc.

Constrained polyethylene acetabular liner

• Primary Device ID: 10885862027627
• NIH Device Record Key: b219380c-e7c1-4422-bc15-d40c1b66644a
• Commercial Distribution Discontinuation: 2024-06-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MCS
• Version Model Number: 146-01-54
• Catalog Number: 146-01-54
• Company DUNS: 157565946
• Company Name: Exactech, 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: false
• Serial Number: true
• 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 Dimensions

• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862027627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040601

FDA Product Code

• KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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: 2025-08-28
• Device Publish Date: 2015-10-30