GUDIDData
eudamed_udi Primary ID: 08680395400894

785-17 (UDI 08680395400894)

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 785-17 - Primary ID 08680395400894

Device Regulatory Overview

The 785-17 (Model/Catalog Number: 785-17) 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 Y061215 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
785-17
Product Code / EMDN
Y061215
Device Name
ORTHOPEDIC HIP AND CALFS
Database Sync Date
2026-08-09 16:28:52

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 785-17?

The registered manufacturer of record for 785-17 is AURAFİX HEALTH PRODUCTS DIŞ TİCARET VE SANAYİ ANONİM ŞİRKETİ.

What is the Primary UDI-DI identifier for 785-17?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08680395400894.

What classification code is assigned to this device?

This device is registered under product classification code Y061215.

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