gudid
Primary ID: 215470
iTero Lumina 25 Disposable Sleeves Box (UDI 215470)
Manufactured by Align Technology, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iTero Lumina 25 Disposable Sleeves Box - Primary ID 215470
Device Regulatory Overview
The iTero Lumina 25 Disposable Sleeves Box (Model/Catalog Number: 215470) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NOF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 215470
- Product Code / EMDN
- NOF
- Device Name
- Disposable single use sleeves box
- Database Sync Date
- 2026-08-09 09:40:14
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 iTero Lumina 25 Disposable Sleeves Box?
The registered manufacturer of record for iTero Lumina 25 Disposable Sleeves Box is Align Technology, Inc..
What is the Primary UDI-DI identifier for iTero Lumina 25 Disposable Sleeves Box?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 215470.
What classification code is assigned to this device?
This device is registered under product classification code NOF.
Similar Classification Devices (NOF)
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