gudid
Primary ID: 212265
Packed iTero Computing Unit RMA 5D Plus (UDI 212265)
Manufactured by Align Technology, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Packed iTero Computing Unit RMA 5D Plus - Primary ID 212265
Device Regulatory Overview
The Packed iTero Computing Unit RMA 5D Plus (Model/Catalog Number: 212265) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NTK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 212265
- Product Code / EMDN
- NTK
- Device Name
- PPC RMAs
- 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 Packed iTero Computing Unit RMA 5D Plus?
The registered manufacturer of record for Packed iTero Computing Unit RMA 5D Plus is Align Technology, Inc..
What is the Primary UDI-DI identifier for Packed iTero Computing Unit RMA 5D Plus?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 212265.
What classification code is assigned to this device?
This device is registered under product classification code NTK.
Similar Classification Devices (NTK)
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