eudamed_udi
Primary ID: 00810049431433
TherAlign (UDI 00810049431433)
Manufactured by Theratogs Inc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TherAlign - Primary ID 00810049431433
Device Regulatory Overview
The TherAlign (Model/Catalog Number: DFLY48A) is a medical device manufactured by Theratogs Inc. This product is indexed under FDA Product Code / Category Classification Y060309 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DFLY48A
- Product Code / EMDN
- Y060309
- Device Name
- Theralign DragonFly TLSO Systems
- Database Sync Date
- 2026-08-09 16:48:36
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 TherAlign?
The registered manufacturer of record for TherAlign is Theratogs Inc.
What is the Primary UDI-DI identifier for TherAlign?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00810049431433.
What classification code is assigned to this device?
This device is registered under product classification code Y060309.
Similar Classification Devices (Y060309)
Other Devices by Theratogs Inc
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