Endorail System
Basic Information
- Brand Name
- Endorail System
- Primary DI
- 08057502310092
- Version / Model
- ESYSTEMGEN2V01A
- Catalog Number
- ESYSTEMGEN2V01A
- Company Name
- ENDOSTART SRL
- Labeler DUNS
- 439228695
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-16
- Public Version
- 2
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 21cadcae-77a5-4313-88ba-9e6b6e8fc246
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67184 | Gastrointestinal endoscope 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 gastrointestinal endoscope (e.g., colonoscope, enteroscope), to facilitate magnetic anchoring or manipulation of the catheter/endoscope, 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 endoscope are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057502310092 | GS1 |
Customer Contacts
- Phone
- +390571843033
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232327 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The device must be stored in a cool and dry place