S-Path Pre-loaded RX Biliary Stent System (80mm)

Primary DI
00860005738229
Brand
S-Path Pre-loaded RX Biliary Stent System (80mm)
Company
ENDO GI MEDICAL LTD
Model
Single-Stent (80mm)
Device description
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent 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 S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 80 mm stent preloaded on the Delivery System.A stent barb cover is provided to facilitate placement of the stent into the endoscope.
Published
2023-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005738229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005738229008600057382298600057382290860005738229

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric biliary stent, non-bioabsorbableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Length80Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246098600omri@EndogI-Medical.com

Regulatory Flags#

DUNS number
532316194
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005738250EndoGI Specialized S-Path Delivery SystemDelivery System2025-04-07
00860005738243EndoGI Specialized S-Path Delivery SystemDelivery System2025-03-21
00860005738236S-Path Biliary Stent System (140mm)Single-Stent (140mm)2023-08-28
00860005738212S-Path Pre-loaded RX Biliary Stent SystemSingle-Stent2020-12-01
00860005738205X-Path Pre-loaded RX-OTW Double Biliary Stents SystemDouble-Stent2020-12-01
10860005738219S-Path Pre-loaded RX Biliary Stent SystemSingle-Stent2020-12-01

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Primary DI, Brand, Company table
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