gudid
Primary ID: OPTICA10-00-009-001-OEM
Varex Imaging (UDI OPTICA10-00-009-001-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 OPTICA10-00-009-001-OEM
Device Regulatory Overview
The Varex Imaging (Model/Catalog Number: OPTICA10-00-009-001-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
- OPTICA10-00-009-001-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
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
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 OPTICA10-00-009-001-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.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint