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
| Code | Name |
|---|---|
| ODC | Endoscope Channel Accessory |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K232327 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08057502310092 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08057502310092 | 08057502310092 | 8057502310092 |
GMDN Terms
| Term | Definition |
|---|---|
| Colonoscope manipulation external magnet | An 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 | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | The device must be stored in a cool and dry place |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +390571843033 | endostart@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 DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08057502310115 | Endorail Set | ESETGEN2V02A | ESETGEN2V02A | 2024-10-16 |
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