MCS 104-28-43

GUDID 10885862013491

Exactech, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 10885862013491
• NIH Device Record Key: ecd2c1c2-fc6f-4541-8931-600ff545cd43
• Commercial Distribution Discontinuation: 2023-06-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MCS
• Version Model Number: 104-28-43
• Catalog Number: 104-28-43
• 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

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862013491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051556

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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: 2025-08-27
• Device Publish Date: 2015-10-30