GUDIDData
eudamed_udi Primary ID: 08680395404953

ORT-17 S (UDI 08680395404953)

Manufactured by AURAFİX HEALTH PRODUCTS DIŞ TİCARET VE SANAYİ ANONİM ŞİRKETİ

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ORT-17 S - Primary ID 08680395404953

Device Regulatory Overview

The ORT-17 S (Model/Catalog Number: ORT-17 S) is a medical device manufactured by AURAFİX HEALTH PRODUCTS DIŞ TİCARET VE SANAYİ ANONİM ŞİRKETİ. This product is indexed under FDA Product Code / Category Classification Y06120601 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ORT-17 S
Product Code / EMDN
Y06120601
Device Name
ORTHOPEDIC ANKLE BRACES
Database Sync Date
2026-08-09 16:29:39

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 ORT-17 S?

The registered manufacturer of record for ORT-17 S is AURAFİX HEALTH PRODUCTS DIŞ TİCARET VE SANAYİ ANONİM ŞİRKETİ.

What is the Primary UDI-DI identifier for ORT-17 S?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08680395404953.

What classification code is assigned to this device?

This device is registered under product classification code Y06120601.

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