gudid
Primary ID: ESYSTEMGEN2V01A
Endorail System (UDI ESYSTEMGEN2V01A)
Manufactured by ENDOSTART SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Endorail System - Primary ID ESYSTEMGEN2V01A
Device Regulatory Overview
The Endorail System (Model/Catalog Number: ESYSTEMGEN2V01A) is a medical device manufactured by ENDOSTART SRL. This product is indexed under FDA Product Code / Category Classification ODC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ESYSTEMGEN2V01A
- Product Code / EMDN
- ODC
- Device Name
- Endorail includes two components to be used in combination called: Endorail Set and Endorail System.Endorail System is reusable and includes the following elements: Endorail Handpiece (EH), Endorail Cart (EC).Before the procedure, the operator prepares the syringe containing the ferromagnetic fluid using the Endorail Solution Syringe (ESS), the spike and the Endorail Powder (EP). The Endorail Balloon Guide (EBG) is a balloon catheter that can be introduced as needed through the endoscope instrument channel during the colonoscopy, if the procedure becomes challenging. Endorail Set does not require to be pre-mounted and does not interfere with the normal examination process. The EBG is advanced beyond the colonoscope tip where the balloon is filled with the ferromagnetic fluid and magnetically anchored with the Endorail Handpiece (EH) placed on the patients abdomen. Once anchored, the colonoscope can be straightened and guided along the catheter. Afterward the EBG can be unlocked, deflated and retrieved.
- Database Sync Date
- 2026-08-09 09:04:28
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 Endorail System?
The registered manufacturer of record for Endorail System is ENDOSTART SRL.
What is the Primary UDI-DI identifier for Endorail System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ESYSTEMGEN2V01A.
What classification code is assigned to this device?
This device is registered under product classification code ODC.
Similar Classification Devices (ODC)
Other Devices by ENDOSTART SRL
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