Austofix Intramedullary Nailing System (UDI 09339430003475)
Manufactured by Australian Orthopaedic Fixations Pty. Ltd.
Device Regulatory Overview
The Austofix Intramedullary Nailing System (Model/Catalog Number: 364855) is a medical device manufactured by Australian Orthopaedic Fixations Pty. Ltd.. This product is indexed under FDA Product Code / Category Classification P09120604 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 364855
- Product Code / EMDN
- P09120604
- Device Name
- Nail Locking Screw | 4.8 x 55mm
- Database Sync Date
- 2026-08-09 16:28:55
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 Austofix Intramedullary Nailing System?
The registered manufacturer of record for Austofix Intramedullary Nailing System is Australian Orthopaedic Fixations Pty. Ltd..
What is the Primary UDI-DI identifier for Austofix Intramedullary Nailing System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09339430003475.
What classification code is assigned to this device?
This device is registered under product classification code P09120604.
Similar Classification Devices (P09120604)
Other Devices by Australian Orthopaedic Fixations Pty. Ltd.
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