Scar Fx (UDI 11012)

Manufactured by Scar Heal

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Scar Fx (Model/Catalog Number: 11012) is a medical device manufactured by Scar Heal. This product is indexed under FDA Product Code / Category Classification MDA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 11012
Product Code / EMDN: MDA
Device Name: Scar Fx Silicone Sheeting 10"x12"
Database Sync Date: 2026-08-09 09:36:28

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Scar Fx?

The registered manufacturer of record for Scar Fx is Scar Heal.

What is the Primary UDI-DI identifier for Scar Fx?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 11012.

What classification code is assigned to this device?

This device is registered under product classification code MDA.

Similar Classification Devices (MDA)

Other Devices by Scar Heal

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