ORT-02B L (UDI 08698779838003)
Manufactured by AURAFİX HEALTH PRODUCTS DIŞ TİCARET VE SANAYİ ANONİM ŞİRKETİ
Device Regulatory Overview
The ORT-02B L (Model/Catalog Number: ORT-02B L) 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 Y060612 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ORT-02B L
- Product Code / EMDN
- Y060612
- Device Name
- ORTHOPEDICS-HAND AND WRIST ORTHOSIS
- Database Sync Date
- 2026-08-09 16:28:47
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ORT-02B L?
The registered manufacturer of record for ORT-02B L is AURAFİX HEALTH PRODUCTS DIŞ TİCARET VE SANAYİ ANONİM ŞİRKETİ.
What is the Primary UDI-DI identifier for ORT-02B L?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08698779838003.
What classification code is assigned to this device?
This device is registered under product classification code Y060612.
Similar Classification Devices (Y060612)
Other Devices by AURAFİX HEALTH PRODUCTS DIŞ TİCARET VE SANAYİ ANONİM ŞİRKETİ
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