gudid
Primary ID: OPTICA10-00-004-005-OEM
Varex Imaging (UDI OPTICA10-00-004-005-OEM)
Manufactured by Varex Imaging Nederland B.V.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Varex Imaging - Primary ID OPTICA10-00-004-005-OEM
Device Regulatory Overview
The Varex Imaging (Model/Catalog Number: OPTICA10-00-004-005-OEM) is a medical device manufactured by Varex Imaging Nederland B.V.. This product is indexed under FDA Product Code / Category Classification IZX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- OPTICA10-00-004-005-OEM
- Product Code / EMDN
- IZX
- Device Name
- x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator)This is a device out of the Optica 10 series
- Database Sync Date
- 2026-08-09 09:26:45
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 Varex Imaging?
The registered manufacturer of record for Varex Imaging is Varex Imaging Nederland B.V..
What is the Primary UDI-DI identifier for Varex Imaging?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OPTICA10-00-004-005-OEM.
What classification code is assigned to this device?
This device is registered under product classification code IZX.
Similar Classification Devices (IZX)
Other Devices by Varex Imaging Nederland B.V.
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