eudamed_udi
Primary ID: 08800046000635
Orthodontic Fixation Screw (UDI 08800046000635)
Manufactured by GNI Co.,Ltd
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Orthodontic Fixation Screw - Primary ID 08800046000635
Device Regulatory Overview
The Orthodontic Fixation Screw (Model/Catalog Number: SA2010) is a medical device manufactured by GNI Co.,Ltd. This product is indexed under FDA Product Code / Category Classification P010299 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SA2010
- Product Code / EMDN
- P010299
- Device Name
- Orthodontic Fixation Screw
- Database Sync Date
- 2026-08-09 17:56:44
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 Orthodontic Fixation Screw?
The registered manufacturer of record for Orthodontic Fixation Screw is GNI Co.,Ltd.
What is the Primary UDI-DI identifier for Orthodontic Fixation Screw?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800046000635.
What classification code is assigned to this device?
This device is registered under product classification code P010299.
Similar Classification Devices (P010299)
Other Devices by GNI Co.,Ltd
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