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
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ODCEndoscope Channel Accessory

Product Code Classifications

CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K232327000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232327000EndorailEndostart S.R.L.2024-03-15ODC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08057502310092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08057502310092080575023100928057502310092

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

PhoneEmail
+390571843033endostart@endostart.com

Regulatory Flags

DUNS number
439228695
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08057502310115Endorail SetESETGEN2V02AESETGEN2V02A2024-10-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957917andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958556andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958587andorate® 3-piece Valve KitGA Health Company LimitedODC2026-03-12
14897106958617andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958624andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958631andorate®Air Water Channel Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-12
14897106958648andorate® Air Water Channel Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-12
10724995247307NAMEDIVATORS INC.ODC2026-03-02
14897106957979andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106958532andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106958549andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106957832Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957849Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957856Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957863Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957900Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957924Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957931Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957962Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957986Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957993Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
00697314195036EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2025-12-05
04953170467325SUCTION VALVE MAJ-1443OLYMPUS MEDICAL SYSTEMS CORP.ODC2025-09-25
04953170467332AIR/WATER VALVE MAJ-1444OLYMPUS MEDICAL SYSTEMS CORP.ODC2025-09-25