Endorail System

Primary DI
08057502310092
Brand
Endorail System
Company
ENDOSTART SRL
Model
ESYSTEMGEN2V01A
Catalog number
ESYSTEMGEN2V01A
Device description
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 patient’s abdomen. Once anchored, the colonoscope can be straightened and guided along the catheter. Afterward the EBG can be unlocked, deflated and retrieved.
Published
2024-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232327000EndorailEndostart S.R.L.2024-03-15ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057502310092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057502310092080575023100928057502310092

GMDN Terms#

Term, Definition table
TermDefinition
Colonoscope manipulation external magnetAn external permanent magnet intended for magnetic coupling with an in situ magnetic balloon catheter, positioned at the distal end of a colonoscope, to facilitate magnetic anchoring or manipulation of the catheter/colonoscope, for e.g., manual colonoscope straightening in cases of a difficult colonoscopy (also known as looping or twisting). It is intended to be placed on the abdomen in the desired position when in use and includes a portable shield with electronic indicators designed to allow safe storage of the device avoiding magnetic interference. The catheter and colonoscope are not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The device must be stored in a cool and dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390571843033endostart@endostart.com

Regulatory Flags#

DUNS number
439228695
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057502310108Endorail SetESETGEN2V02AESETGEN2V02A2024-10-16
08057502310115Endorail SetESETGEN2V02AESETGEN2V02A2024-10-16

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