GUDIDData
eudamed_udi Primary ID: 00768627795012

Comfort Cool Ulnar/Dorsal Wrist Orthotic, RS (UDI 00768627795012)

Manufactured by North Coast Medical Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Comfort Cool Ulnar/Dorsal Wrist Orthotic, RS - Primary ID 00768627795012

Device Regulatory Overview

The Comfort Cool Ulnar/Dorsal Wrist Orthotic, RS (Model/Catalog Number: NC79501) is a medical device manufactured by North Coast Medical Inc.. This product is indexed under FDA Product Code / Category Classification Y060612 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
NC79501
Product Code / EMDN
Y060612
Device Name
Comfort Cool Ulnar/Dorsal Wrist Orthotic
Database Sync Date
2026-08-09 16:30:17

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Comfort Cool Ulnar/Dorsal Wrist Orthotic, RS?

The registered manufacturer of record for Comfort Cool Ulnar/Dorsal Wrist Orthotic, RS is North Coast Medical Inc..

What is the Primary UDI-DI identifier for Comfort Cool Ulnar/Dorsal Wrist Orthotic, RS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00768627795012.

What classification code is assigned to this device?

This device is registered under product classification code Y060612.

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