gudid
Primary ID: SAO-DROU-0016
SmartArch (UDI SAO-DROU-0016)
Manufactured by Smarter Alloys Inc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SmartArch - Primary ID SAO-DROU-0016
Device Regulatory Overview
The SmartArch (Model/Catalog Number: SAO-DROU-0016) is a medical device manufactured by Smarter Alloys Inc. This product is indexed under FDA Product Code / Category Classification DZC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SAO-DROU-0016
- Product Code / EMDN
- DZC
- Device Name
- SmartArch .016" (0.406mm) Round Damon Upper Orthodontic CuNiTi Archwire
- Database Sync Date
- 2026-08-09 09:01:11
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 SmartArch?
The registered manufacturer of record for SmartArch is Smarter Alloys Inc.
What is the Primary UDI-DI identifier for SmartArch?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SAO-DROU-0016.
What classification code is assigned to this device?
This device is registered under product classification code DZC.
Similar Classification Devices (DZC)
Other Devices by Smarter Alloys Inc
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