Endorail Set
Basic Information
- Brand Name
- Endorail Set
- Primary DI
- 08057502310108
- Version / Model
- ESETGEN2V02A
- Catalog Number
- ESETGEN2V02A
- 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
- 5b774d1c-83ba-475c-b69e-f3a279147ff1
Device Description
Endorail includes two components to be used in combination called: Endorail Set and Endorail System. Endorail Set is disposable and includes the following elements: • Endorail Balloon Guide (EBG), • Endorail Solution Syringe (ESS), • Endorail Powder (EP), • Spike. Before the procedure, the operator prepares the syringe containing the ferromagnetic fluid using the ESS, the spike and the EP. The 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
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 67185 | Gastrointestinal endoscope manipulation magnetic balloon catheter | A flexible tube with an inflatable balloon at its distal tip intended to be introduced through the working channel of a gastrointestinal endoscope (e.g., colonoscope, enteroscope) and filled with a ferromagnetic material, to facilitate magnetic coupling with an external magnet (not included) for 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 includes the ferromagnetic material, typically provided as a solution of iron particles; devices intended to support catheter function (e.g., balloon fill syringe) may be included. This is a single-patient reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08057502310115 | GS1 | 4 units carton box | 4 | In Commercial Distribution | |
| Primary | 08057502310108 | GS1 |
Customer Contacts
- Phone
- +390571843033
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232327 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry place
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius