gudid
Primary ID: MOBETRON
MOBETRON (UDI MOBETRON)
Manufactured by INTRAOP MEDICAL CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MOBETRON - Primary ID MOBETRON
Device Regulatory Overview
The MOBETRON (Model/Catalog Number: MOBETRON) is a medical device manufactured by INTRAOP MEDICAL CORPORATION. This product is indexed under FDA Product Code / Category Classification LHN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- MOBETRON
- Product Code / EMDN
- LHN
- Device Name
- The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for Electron Beam IORT. Electron beam IORT (Intra-Operative Radiation Therapy) is the use of electron radiation during surgery to treat both malignant and benign tumors. The Mobetron is not intended for unrestricted beam production. Extensive beam testing should be done in a stray radiation shielded room or a strictly controlled area. MOBETRON S/N: 72
- Database Sync Date
- 2026-08-09 09:49:15
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 MOBETRON?
The registered manufacturer of record for MOBETRON is INTRAOP MEDICAL CORPORATION.
What is the Primary UDI-DI identifier for MOBETRON?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MOBETRON.
What classification code is assigned to this device?
This device is registered under product classification code LHN.
Similar Classification Devices (LHN)
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