GUDIDData
eudamed_udi Primary ID: 08680853101035

BASIC THUMB SPLINT-WITH AN ALUMINUM THUMB SUPPORT-RIGHT-XL (UDI 08680853101035)

Manufactured by HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BASIC THUMB SPLINT-WITH AN ALUMINUM THUMB SUPPORT-RIGHT-XL - Primary ID 08680853101035

Device Regulatory Overview

The BASIC THUMB SPLINT-WITH AN ALUMINUM THUMB SUPPORT-RIGHT-XL (Model/Catalog Number: ARH15-R-XL) is a medical device manufactured by HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ. This product is indexed under FDA Product Code / Category Classification Y060613 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ARH15-R-XL
Product Code / EMDN
Y060613
Device Name
HAND&WRIST
Database Sync Date
2026-08-09 16:30:06

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 BASIC THUMB SPLINT-WITH AN ALUMINUM THUMB SUPPORT-RIGHT-XL?

The registered manufacturer of record for BASIC THUMB SPLINT-WITH AN ALUMINUM THUMB SUPPORT-RIGHT-XL is HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ.

What is the Primary UDI-DI identifier for BASIC THUMB SPLINT-WITH AN ALUMINUM THUMB SUPPORT-RIGHT-XL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08680853101035.

What classification code is assigned to this device?

This device is registered under product classification code Y060613.

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