X-Path Pre-loaded RX-OTW Double Biliary Stents System
Basic Information
- Brand Name
- X-Path Pre-loaded RX-OTW Double Biliary Stents System
- Primary DI
- 00860005738205
- Version / Model
- Double-Stent
- Company Name
- ENDO GI MEDICAL LTD
- Labeler DUNS
- 532316194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-01
- Public Version
- 1
- Public Version Date
- 2020-12-09
- Public Version Status
- New
- Public Device Record Key
- 10bd00aa-9fa2-48cd-8782-3a7c3da49724
Device Description
The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI Delivery System enables insertion and placement of two stents in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
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
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43764 | Polymeric biliary stent, non-bioabsorbable | A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860005738205 | GS1 | ||||
| Package | 10860005738202 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +97246098600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193600 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Length | 110 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius